The following data is part of a premarket notification filed by Microline Pentax, Inc. with the FDA for Re-new Laparoscopic Instruments.
| Device ID | K962119 |
| 510k Number | K962119 |
| Device Name: | RE-NEW LAPAROSCOPIC INSTRUMENTS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MICROLINE PENTAX, INC. 181 ELLIOT ST. SUITE 915 Beverly, MA 01915 |
| Contact | Hughes De Laforcade |
| Correspondent | Hughes De Laforcade MICROLINE PENTAX, INC. 181 ELLIOT ST. SUITE 915 Beverly, MA 01915 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-31 |
| Decision Date | 1996-08-09 |
| Summary: | summary |