The following data is part of a premarket notification filed by Colla-tec, Inc. with the FDA for Colla-tec Absorbable Collagen Membrane.
| Device ID | K924408 |
| 510k Number | K924408 |
| Device Name: | COLLA-TEC ABSORBABLE COLLAGEN MEMBRANE |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | COLLA-TEC, INC. P.O. BOX 688 Plainsboro, NJ 08536 |
| Contact | Judith E O'grady |
| Correspondent | Judith E O'grady COLLA-TEC, INC. P.O. BOX 688 Plainsboro, NJ 08536 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-01 |
| Decision Date | 1995-08-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841336100848 | K924408 | 000 |
| 30381780072571 | K924408 | 000 |
| 30381780072588 | K924408 | 000 |
| 30381780072595 | K924408 | 000 |
| 30381780038485 | K924408 | 000 |
| 30381780038492 | K924408 | 000 |
| 30381780038508 | K924408 | 000 |
| 30381780070751 | K924408 | 000 |
| 30381780070775 | K924408 | 000 |
| 00841336100824 | K924408 | 000 |
| 00841336100831 | K924408 | 000 |
| 30381780070737 | K924408 | 000 |