The following data is part of a premarket notification filed by K. W. Griffen Co. with the FDA for Bio-dressing, Sterile Island Dressing.
| Device ID | K961098 |
| 510k Number | K961098 |
| Device Name: | BIO-DRESSING, STERILE ISLAND DRESSING |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | K. W. GRIFFEN CO. 100 PEARL ST. Norwalk, CT 06850 |
| Contact | David M Pieratos |
| Correspondent | David M Pieratos K. W. GRIFFEN CO. 100 PEARL ST. Norwalk, CT 06850 |
| Product Code | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-19 |
| Decision Date | 1996-05-03 |