The following data is part of a premarket notification filed by Microline Pentax, Inc. with the FDA for Quick Switch Laparoscopic Instruments.
| Device ID | K932648 |
| 510k Number | K932648 |
| Device Name: | QUICK SWITCH LAPAROSCOPIC INSTRUMENTS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MICROLINE PENTAX, INC. 199 NEWBURY ST. Devers, MA 01923 |
| Contact | De Laforcade |
| Correspondent | De Laforcade MICROLINE PENTAX, INC. 199 NEWBURY ST. Devers, MA 01923 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-02 |
| Decision Date | 1993-10-12 |