The following data is part of a premarket notification filed by Rmds, Inc. with the FDA for Favc-m: Femoral Artery Vascular Clamp-mobile (model M100-m200) Favc-m Femoral Artery Vascular Clamp-mobile Adj Belt 6005.
| Device ID | K970027 |
| 510k Number | K970027 |
| Device Name: | FAVC-M: FEMORAL ARTERY VASCULAR CLAMP-MOBILE (MODEL M100-M200) FAVC-M FEMORAL ARTERY VASCULAR CLAMP-MOBILE ADJ BELT 6005 |
| 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 | 1997-01-03 |
| Decision Date | 1997-08-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20815614020665 | K970027 | 000 |
| 10815614020651 | K970027 | 000 |
| 10815614020644 | K970027 | 000 |