The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Harmonic.
| Device ID | K012571 |
| 510k Number | K012571 |
| Device Name: | REPROCESSED HARMONIC |
| Classification | Scalpel, Ultrasonic, 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 | NLQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-09 |
| Decision Date | 2001-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888551019040 | K012571 | 000 |
| 10888551019033 | K012571 | 000 |
| 10888551019026 | K012571 | 000 |
| 10888551019019 | K012571 | 000 |
| 10888551019002 | K012571 | 000 |
| 10888551018999 | K012571 | 000 |
| 10888551018913 | K012571 | 000 |
| 10888551018869 | K012571 | 000 |