The following data is part of a premarket notification filed by Medcare Custom Packaging, Inc. with the FDA for Pelvic Exam Tray.
| Device ID | K934732 |
| 510k Number | K934732 |
| Device Name: | PELVIC EXAM TRAY |
| Classification | Spatula, Cervical, Cytological |
| Applicant | MEDCARE CUSTOM PACKAGING, INC. WINCHESTER ST. West Swanzey, NH 03469 -0069 |
| Contact | William A Hays |
| Correspondent | William A Hays MEDCARE CUSTOM PACKAGING, INC. WINCHESTER ST. West Swanzey, NH 03469 -0069 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-29 |
| Decision Date | 1994-12-30 |