The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Laparoscopic Electric Instuments.
| Device ID | K012598 |
| 510k Number | K012598 |
| Device Name: | REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS |
| Classification | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Applicant | STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Contact | Patrick F Fleischhacker |
| Correspondent | Patrick F Fleischhacker 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 | 2001-08-10 |
| Decision Date | 2001-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888551024952 | K012598 | 000 |
| 10888551010078 | K012598 | 000 |
| 10888551012942 | K012598 | 000 |
| 10888551012997 | K012598 | 000 |
| 10888551013017 | K012598 | 000 |
| 10888551013024 | K012598 | 000 |
| 10888551019118 | K012598 | 000 |
| 10888551019583 | K012598 | 000 |
| 10888551019644 | K012598 | 000 |
| 10888551024945 | K012598 | 000 |
| 10888551010061 | K012598 | 000 |