The following data is part of a premarket notification filed by Vineland Medical Products, Inc. with the FDA for Accuscope(tm) & Accuscope Ii(tm).
| Device ID | K913365 |
| 510k Number | K913365 |
| Device Name: | ACCUSCOPE(TM) & ACCUSCOPE II(TM) |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | VINELAND MEDICAL PRODUCTS, INC. P.O. BOX 575 1471 E. CHESTNUT AVE. Vineland, NJ 08360 |
| Contact | Don Pasquale |
| Correspondent | Don Pasquale VINELAND MEDICAL PRODUCTS, INC. P.O. BOX 575 1471 E. CHESTNUT AVE. Vineland, NJ 08360 |
| Product Code | HEX |
| CFR Regulation Number | 884.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-29 |
| Decision Date | 1992-04-27 |