The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Harmonic Scalpel.
| Device ID | K111794 |
| 510k Number | K111794 |
| Device Name: | REPROCESSED HARMONIC SCALPEL |
| Classification | Scalpel, Ultrasonic, Reprocessed |
| Applicant | STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 -5562 |
| Contact | Onya Dendinger |
| Correspondent | Onya Dendinger STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 -5562 |
| 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 | 2011-06-27 |
| Decision Date | 2012-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888551018951 | K111794 | 000 |