The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Vessel Sealer.
| Device ID | K123096 |
| 510k Number | K123096 |
| Device Name: | REPROCESSED VESSEL SEALER |
| Classification | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Applicant | STERILMED, INC. 11400 73rd Ave N Ste 100 Maple Grove, MN 55369 |
| Contact | Jason Skramsted |
| Correspondent | Jason Skramsted STERILMED, INC. 11400 73rd Ave N Ste 100 Maple Grove, MN 55369 |
| Product Code | NUJ |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-02 |
| Decision Date | 2013-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888551008013 | K123096 | 000 |
| 10888551007979 | K123096 | 000 |