The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Codman Ethisorb Dura Patch.
| Device ID | K991413 |
| 510k Number | K991413 |
| Device Name: | CODMAN ETHISORB DURA PATCH |
| Classification | Dura Substitute |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Deana Boushell |
| Correspondent | Deana Boushell JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | GXQ |
| CFR Regulation Number | 882.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-23 |
| Decision Date | 2000-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704042709 | K991413 | 000 |
| 10886704042693 | K991413 | 000 |
| 10886704042686 | K991413 | 000 |