The following data is part of a premarket notification filed by Rmds, Inc. with the FDA for Favc-hh: Femoral Artery Vascular Clamp-hand Held: 1/2 & 3 Pounds (rmds810t/815t/820t).
| Device ID | K973216 |
| 510k Number | K973216 |
| Device Name: | FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 POUNDS (RMDS810T/815T/820T) |
| Classification | Clamp, Vascular |
| Applicant | RMDS, INC. 1208 SE 104TH AVE. Vancouver, WA 98664 -4740 |
| Contact | Delbert L Rice |
| Correspondent | Delbert L Rice RMDS, INC. 1208 SE 104TH AVE. Vancouver, WA 98664 -4740 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-27 |
| Decision Date | 1997-11-25 |