The following data is part of a premarket notification filed by Microline Pentax, Inc. with the FDA for Microline Inc. Reusable Laparoscopic Clip Applier With Implantable Titanium Clips, Model M/l-10.
| Device ID | K013695 |
| 510k Number | K013695 |
| Device Name: | MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MICROLINE PENTAX, INC. 70 WALNUT ST. Wellesley, MA 02481 -2102 |
| Contact | Jacqueline E Masse |
| Correspondent | Jacqueline E Masse MICROLINE PENTAX, INC. 70 WALNUT ST. Wellesley, MA 02481 -2102 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-07 |
| Decision Date | 2002-01-08 |
| Summary: | summary |