The following data is part of a premarket notification filed by Puritas Health Care, Inc. with the FDA for Silclamps Degania Silicone.
| Device ID | K920501 |
| 510k Number | K920501 |
| Device Name: | SILCLAMPS DEGANIA SILICONE |
| Classification | Clamp, Vascular |
| Applicant | PURITAS HEALTH CARE, INC. 76 STONY HILL VILLAGE Brookfield, CT 06804 |
| Contact | Arcovio, Jr. |
| Correspondent | Arcovio, Jr. PURITAS HEALTH CARE, INC. 76 STONY HILL VILLAGE Brookfield, CT 06804 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-04 |
| Decision Date | 1992-06-02 |