The following data is part of a premarket notification filed by Imagyn Medical, Inc. with the FDA for Imagyn Medical Videoscopy Syst W/irrig Pump/access.
| Device ID | K911163 |
| 510k Number | K911163 |
| Device Name: | IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP/ACCESS |
| Classification | Camera, Television, Endoscopic, Without Audio |
| Applicant | IMAGYN MEDICAL, INC. 920 CALLE NEGOCIO San Clemente, CA 92672 |
| Contact | Van Osdel |
| Correspondent | Van Osdel IMAGYN MEDICAL, INC. 920 CALLE NEGOCIO San Clemente, CA 92672 |
| Product Code | FWF |
| CFR Regulation Number | 878.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-15 |
| Decision Date | 1991-06-03 |