The following data is part of a premarket notification filed by Alton Dean Medical, Inc. with the FDA for Orcepad.
| Device ID | K875123 |
| 510k Number | K875123 |
| Device Name: | ORCEPAD |
| Classification | Table, Obstetrical, Ac-powered (and Accessories) |
| Applicant | ALTON DEAN MEDICAL, INC. 40 SOUTH REDWOOD RD. SUITE 102 North Salt Lake City, UT 84054 |
| Contact | Dixon Ford |
| Correspondent | Dixon Ford ALTON DEAN MEDICAL, INC. 40 SOUTH REDWOOD RD. SUITE 102 North Salt Lake City, UT 84054 |
| Product Code | HDD |
| CFR Regulation Number | 884.4900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-15 |
| Decision Date | 1988-06-21 |