The following data is part of a premarket notification filed by Gynescope Corp. with the FDA for Gynecological Instrumentation.
| Device ID | K895225 |
| 510k Number | K895225 |
| Device Name: | GYNECOLOGICAL INSTRUMENTATION |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | GYNESCOPE CORP. 1810 JOSEPH LLOYD PKWY. Willoughby, OH 44094 |
| Contact | Scott C Marlow |
| Correspondent | Scott C Marlow GYNESCOPE CORP. 1810 JOSEPH LLOYD PKWY. Willoughby, OH 44094 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-14 |
| Decision Date | 1990-03-05 |