The following data is part of a premarket notification filed by Research Medical, Inc. with the FDA for Rmi Sofclamp.
| Device ID | K920676 |
| 510k Number | K920676 |
| Device Name: | RMI SOFCLAMP |
| Classification | Clip, Vascular |
| Applicant | RESEARCH MEDICAL, INC. 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Contact | Rd Hibbert |
| Correspondent | Rd Hibbert RESEARCH MEDICAL, INC. 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Product Code | DSS |
| CFR Regulation Number | 870.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-14 |
| Decision Date | 1992-04-15 |