The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Femoral Compression Device.
| Device ID | K120204 |
| 510k Number | K120204 |
| Device Name: | REPROCESSED FEMORAL COMPRESSION DEVICE |
| Classification | Clamp, Vascular, Reprocessed |
| Applicant | STERILMED, INC. 11140 73RD AVE. NORTH Maple Grove, MN 55369 |
| Contact | Jason Skramsted |
| Correspondent | Jason Skramsted STERILMED, INC. 11140 73RD AVE. NORTH Maple Grove, MN 55369 |
| Product Code | NMF |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-23 |
| Decision Date | 2012-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888551039482 | K120204 | 000 |
| 10888551034814 | K120204 | 000 |