The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Guidewires.
| Device ID | K012556 |
| 510k Number | K012556 |
| Device Name: | REPROCESSED GUIDEWIRES |
| Classification | Catheter, Biliary, Reprocessed |
| Applicant | STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Contact | Patrick Fleischhacker |
| Correspondent | Patrick Fleischhacker STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Product Code | NML |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-08 |
| Decision Date | 2002-04-29 |
| Summary: | summary |