The following data is part of a premarket notification filed by Gynescope Corp. with the FDA for Modified Metal Speculum & Special Bullet Forceps.
| Device ID | K902019 |
| 510k Number | K902019 |
| Device Name: | MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS |
| Classification | Speculum, Vaginal, Metal |
| 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 | HDF |
| CFR Regulation Number | 884.4520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-03 |
| Decision Date | 1990-06-07 |