Medical Device Establishment Renew Form

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Medical Device Registration Form

Establishment Information

Establishment Name

City

Country

FDA Registration Number

Street Address

State

Postal Code

DUNS Number

Client Contact Person Information

Contact Person Name

Job Title

Tel Number

If different from above establishment, please provide your company information below:

Street Address

State

City

Postal Code

Country

Client Operation Type

Please check the box that applies to you

Manufacturer

Contract Manufacturer

Contract Sterilizer

Developer

Initial Importer

Foreign Exporter

Relabeler

Other (Explain)

US FDA Initial Importer (US Responsible Party for FDA Compliance)

Initial Importer Name

DUNS Number

FDA Registration Number

Address

Phone Number

Manufacturer

Manufacturer Name

FDA Registration Number

Address

Tel Number

*Medical devices must be a finished product. If you have more devices, please email the rest to ask@provisionfda.com.

Medical Device - 1

Proprietary Name

Device Classification

Common Name

Product Code

510(k) Number

Medical Device - 2

Proprietary Name

Device Classification

Common Name

Product Code

510(k) Number

Proprietary Name

Device Classification

Common Name

Product Code

510(k) Number

Medical Device - 4

Proprietary Name

Device Classification

Common Name

Product Code

510(k) Number

Proprietary Name

Device Classification

Common Name

Product Code

510(k) Number

How did you hear about us?

Google search

Newspaper or Magazine

Instagram

Facebook

Youtube

Website

Trade Show

Naver

Referred by

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Thanks for submitting!

Medical Device - 5

Medical Device - 3

13925 City Center Dr. Suite 200, Chino Hills, CA 91709 | Phone: +1-909-493-3276 (office) | Email: ask@provisionfda.com

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