The following data is part of a premarket notification filed by K. W. Griffen Co. with the FDA for Fluff Gauze Bandage, Sterile & Non-sterile.
| Device ID | K953810 |
| 510k Number | K953810 |
| Device Name: | FLUFF GAUZE BANDAGE, STERILE & NON-STERILE |
| Classification | Gauze/sponge, Internal |
| 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 | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-08 |
| Decision Date | 1995-09-14 |