The following data is part of a premarket notification filed by Acutek Adhesive Specialties, Inc. with the FDA for Acutek's Hydrocolloid Wound Dressing, Tib 197012.
| Device ID | K974892 |
| 510k Number | K974892 |
| Device Name: | ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012 |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | ACUTEK ADHESIVE SPECIALTIES, INC. 540 NORTH OAK ST. Inglewood, CA 90302 |
| Contact | Greg Holland |
| Correspondent | Greg Holland ACUTEK ADHESIVE SPECIALTIES, INC. 540 NORTH OAK ST. Inglewood, CA 90302 |
| Product Code | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-30 |
| Decision Date | 1998-10-13 |