The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Heart Stabilizers And Positioners.
| Device ID | K063844 |
| 510k Number | K063844 |
| Device Name: | REPROCESSED HEART STABILIZERS AND POSITIONERS |
| Classification | Stabilizer, Heart, Non-compression, Reprocessed |
| Applicant | STERILMED, INC. 11140 73RD AVE. NORTH Minneapolis, MN 55369 |
| Contact | Dennis Toussaint |
| Correspondent | Dennis Toussaint STERILMED, INC. 11140 73RD AVE. NORTH Minneapolis, MN 55369 |
| Product Code | NQG |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-26 |
| Decision Date | 2007-03-15 |
| Summary: | summary |