The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Harmonic Shear.
| Device ID | K132566 |
| 510k Number | K132566 |
| Device Name: | REPROCESSED HARMONIC SHEAR |
| Classification | Scalpel, Ultrasonic, Reprocessed |
| Applicant | STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Contact | Skramsted |
| Correspondent | Skramsted STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Product Code | NLQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-15 |
| Decision Date | 2014-06-14 |
| Summary: | summary |