The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Closure System.
| Device ID | K133414 |
| 510k Number | K133414 |
| Device Name: | REPROCESSED CLOSURE SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery, Reprocessed |
| Applicant | STERILMED, INC. 11400 73RD AVENUE NORTH Maple Grove, MN 55369 |
| Contact | Jason Skramsted |
| Correspondent | Jason Skramsted STERILMED, INC. 11400 73RD AVENUE NORTH Maple Grove, MN 55369 |
| Product Code | NLM |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | GEJ |
| Subsequent Product Code | HCF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-07 |
| Decision Date | 2014-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888551007945 | K133414 | 000 |