The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Duragen Dural Graft Matrix.
| Device ID | K982180 |
| 510k Number | K982180 |
| Device Name: | DURAGEN DURAL GRAFT MATRIX |
| Classification | Dura Substitute |
| Applicant | INTEGRA LIFESCIENCES CORP. 105 MORGAN LANE Plainsboro, NJ 08536 |
| Contact | Judith E O'grady |
| Correspondent | Judith E O'grady INTEGRA LIFESCIENCES CORP. 105 MORGAN LANE Plainsboro, NJ 08536 |
| Product Code | GXQ |
| CFR Regulation Number | 882.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-22 |
| Decision Date | 1999-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780023616 | K982180 | 000 |
| 30381780023603 | K982180 | 000 |
| 10381780023593 | K982180 | 000 |
| 30381780023580 | K982180 | 000 |
| 10381780023579 | K982180 | 000 |
| 30381780023566 | K982180 | 000 |
| 10381780023555 | K982180 | 000 |
| 30381780023542 | K982180 | 000 |
| 10381780023531 | K982180 | 000 |