The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Harmonic Focus Shears + Adaptive Tissue Technology.
| Device ID | K190610 |
| 510k Number | K190610 |
| Device Name: | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology |
| Classification | Scalpel, Ultrasonic, Reprocessed |
| Applicant | Sterilmed, Inc. 5010 Cheshire Parkway N, Suite 2 Plymouth, MN 55446 |
| Contact | Jan Flegeau |
| Correspondent | Jan Flegeau Sterilmed, Inc. 5010 Cheshire Parkway N, Suite 2 Plymouth, MN 55446 |
| 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 | 2019-03-11 |
| Decision Date | 2019-08-15 |