The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Harmonic Scalpels.
| Device ID | K050343 |
| 510k Number | K050343 |
| Device Name: | REPROCESSED HARMONIC SCALPELS |
| Classification | Scalpel, Ultrasonic, Reprocessed |
| Applicant | STERILMED, INC. 11400 73RD. AVE. N. STE. 100 Maple Grove, MN 55369 |
| Contact | Bruce Lester |
| Correspondent | Bruce Lester STERILMED, INC. 11400 73RD. AVE. N. STE. 100 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 | 2005-02-11 |
| Decision Date | 2005-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888551010900 | K050343 | 000 |
| 10888551010115 | K050343 | 000 |
| 10888551010092 | K050343 | 000 |