The following data is part of a premarket notification filed by Degania Silicone, Ltd. with the FDA for Degania Silicone Identi Loops.
| Device ID | K981956 |
| 510k Number | K981956 |
| Device Name: | DEGANIA SILICONE IDENTI LOOPS |
| Classification | Clamp, Vascular |
| Applicant | DEGANIA SILICONE, LTD. DEGANIA BET Emek Hayarden, IL 15130 |
| Contact | Bette Lubin |
| Correspondent | Bette Lubin DEGANIA SILICONE, LTD. DEGANIA BET Emek Hayarden, IL 15130 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-04 |
| Decision Date | 1998-07-09 |
| Summary: | summary |