FDA Medical Device Registration Form

1. Establishment Details
* Establishment Name
* Street Address
* City				* State
* Country				* Postal Code
FDA Registration Number				DUNS Number
2. Establishment Contact
* Name of Contact Person
* Job Title
* Mailing Address
* City				* State
* Country				* Postal Code
* Tel Number				* E-Mail
Other business Names
3. Type of Operation
Manufacturer Contract Manufacturer Contract Sterilizer Specification Developer Initial Importer Foreign Exporter Relabeler Other (Explain)

4. US Importer / Distributor
US Importer Name
FDA Registration Number				DUNS Number
Address
E-mail				Tel Number
5.1 Device Listing Information - 1
* Proprietary Name
* Common Name
Device Class Device Code 510 (K) Number
5.2 Device Listing Information - 2
Proprietary Name
Common Name
Device Class Device Code 510 (K) Number
5.3 Device Listing Information - 3
Proprietary Name
Common Name
Device Class Device Code 510 (K) Number
5.4 Device Listing Information - 4
Proprietary Name
Common Name
Device Class Device Code 510 (K) Number
5.5 Device Listing Information - 5
Proprietary Name
Common Name
Device Class Device Code 510 (K) Number
6. US FDA Medical Device Registration Form Submitter Information
Submitter Name Job Title Submitter E-mail