The following data is part of a premarket notification filed by Medical Products Div. with the FDA for Hierspec Speculum.
| Device ID | K061339 |
| 510k Number | K061339 |
| Device Name: | HIERSPEC SPECULUM |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | MEDICAL PRODUCTS DIV. 2410 EXECUTIVE DRIVE Indianapolis, IN 46241 |
| Contact | Thomas W Copeland |
| Correspondent | Thomas W Copeland MEDICAL PRODUCTS DIV. 2410 EXECUTIVE DRIVE Indianapolis, IN 46241 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-15 |
| Decision Date | 2006-09-19 |
| Summary: | summary |