The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Vessel Sealer.
| Device ID | K152134 |
| 510k Number | K152134 |
| Device Name: | Reprocessed Vessel Sealer |
| Classification | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Applicant | STERILMED, INC. 5010 Cheshire Pkwy Ste 2 Plymouth, MN 55446 |
| Contact | Patricia Kaufman |
| Correspondent | Ming Cheng Chew LIBRA MEDICAL 8401 73RD AVE NORTH, SUITE 63 Brooklyn Park, MN 55428 |
| Product Code | NUJ |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-31 |
| Decision Date | 2016-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888551044462 | K152134 | 000 |