The following data is part of a premarket notification filed by Puritas Health Care, Inc. with the FDA for Puritas 100% Cotton Absorb Oper Room Surg Towels.
| Device ID | K912542 |
| 510k Number | K912542 |
| Device Name: | PURITAS 100% COTTON ABSORB OPER ROOM SURG TOWELS |
| Classification | Drape, Surgical |
| Applicant | PURITAS HEALTH CARE, INC. 76 STONY HILL VILLAGE Brookfield, CT 06804 |
| Contact | Joseph A Arcovio |
| Correspondent | Joseph A Arcovio PURITAS HEALTH CARE, INC. 76 STONY HILL VILLAGE Brookfield, CT 06804 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-10 |
| Decision Date | 1991-07-23 |