The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Heliderm Collagen Wound Dressings 0.5 Gram And 1.0 Gram.
| Device ID | K990086 |
| 510k Number | K990086 |
| Device Name: | HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM |
| Classification | Dressing, Wound, Drug |
| 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 | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-11 |
| Decision Date | 1999-03-31 |
| Summary: | summary |