The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Endoscopic Trocars.
| Device ID | K111002 |
| 510k Number | K111002 |
| Device Name: | REPROCESSED ENDOSCOPIC TROCARS |
| Classification | Laparoscope, General & Plastic Surgery, Reprocessed |
| Applicant | STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 -5562 |
| Contact | Garrett Ahlborg |
| Correspondent | Garrett Ahlborg STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 -5562 |
| Product Code | NLM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-11 |
| Decision Date | 2011-07-18 |
| Summary: | summary |