The following data is part of a premarket notification filed by Pharmaseal Laboratories with the FDA for Pelvic Exam Tray.
| Device ID | K800874 |
| 510k Number | K800874 |
| Device Name: | PELVIC EXAM TRAY |
| Classification | Pad, Menstrual, Unscented |
| Applicant | PHARMASEAL LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HHD |
| CFR Regulation Number | 884.5435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-17 |
| Decision Date | 1980-05-08 |