The following data is part of a premarket notification filed by Martin Medical with the FDA for Martin Medical Pro-spec Small Vaginal Speculum.
| Device ID | K863275 |
| 510k Number | K863275 |
| Device Name: | MARTIN MEDICAL PRO-SPEC SMALL VAGINAL SPECULUM |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | MARTIN MEDICAL 36270 W. 103RD ST. P.O. BOX 590 Desoto, KS 66018 |
| Contact | Randy Kilburn |
| Correspondent | Randy Kilburn MARTIN MEDICAL 36270 W. 103RD ST. P.O. BOX 590 Desoto, KS 66018 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-25 |
| Decision Date | 1986-09-02 |