The following data is part of a premarket notification filed by Puritas Health Care, Inc. with the FDA for Identi Loops Degania Silicone.
Device ID | K920104 |
510k Number | K920104 |
Device Name: | IDENTI LOOPS DEGANIA SILICONE |
Classification | Clip, 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 | DSS |
CFR Regulation Number | 870.3250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-01-09 |
Decision Date | 1992-04-20 |