The following data is part of a premarket notification filed by Imagyn Medical, Inc. with the FDA for Imagyn Microlap And Micro Lap-gold Laparoscopes.
| Device ID | K965055 |
| 510k Number | K965055 |
| Device Name: | IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | IMAGYN MEDICAL, INC. 27651 LA PAZ RD. Laguna Niguel, CA 92656 -3917 |
| Contact | Debra A Rinderer |
| Correspondent | Debra A Rinderer IMAGYN MEDICAL, INC. 27651 LA PAZ RD. Laguna Niguel, CA 92656 -3917 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-18 |
| Decision Date | 1997-03-06 |
| Summary: | summary |