The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Scissor Tips.
| Device ID | K073613 |
| 510k Number | K073613 |
| Device Name: | REPROCESSED SCISSOR TIPS |
| Classification | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Applicant | STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Contact | Joshua Clarin |
| Correspondent | Joshua Clarin STERILMED, INC. 11400 73RD AVE. NORTH 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 | 2007-12-21 |
| Decision Date | 2008-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888551034739 | K073613 | 000 |
| 10888551001786 | K073613 | 000 |
| 10888551001793 | K073613 | 000 |
| 10888551001809 | K073613 | 000 |
| 10888551001816 | K073613 | 000 |
| 10888551001823 | K073613 | 000 |
| 10888551004930 | K073613 | 000 |
| 10888551004947 | K073613 | 000 |
| 10888551004954 | K073613 | 000 |
| 10888551004961 | K073613 | 000 |
| 10888551010399 | K073613 | 000 |
| 10888551010405 | K073613 | 000 |
| 10888551010412 | K073613 | 000 |
| 10888551034708 | K073613 | 000 |
| 10888551034715 | K073613 | 000 |
| 10888551034722 | K073613 | 000 |
| 10888551001779 | K073613 | 000 |