The following data is part of a premarket notification filed by Precise Optics with the FDA for Precision Optics Corporation Laparoscope.
| Device ID | K911744 |
| 510k Number | K911744 |
| Device Name: | PRECISION OPTICS CORPORATION LAPAROSCOPE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | PRECISE OPTICS 22 EAST BROADWAY Gardner, MA 01440 |
| Contact | Francis L.pugsley |
| Correspondent | Francis L.pugsley PRECISE OPTICS 22 EAST BROADWAY Gardner, MA 01440 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-18 |
| Decision Date | 1991-07-26 |