The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Cordless Ultrasonic Dissection Device.
| Device ID | K143562 |
| 510k Number | K143562 |
| Device Name: | Reprocessed Cordless Ultrasonic Dissection Device |
| Classification | Scalpel, Ultrasonic, Reprocessed |
| Applicant | STERILMED, INC. 11400 73RD AVE. N Maple Grove, MN 55369 |
| Contact | Nicole Boser |
| Correspondent | Julie Bodmer LIBRA MEDICAL 8401 73RD AVE NORTH, SUITE 63 Brooklyn Park, MN 55448 |
| 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 | 2014-12-16 |
| Decision Date | 2015-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888551008020 | K143562 | 000 |