The following data is part of a premarket notification filed by Clearspec Llc with the FDA for Clearspec Single Use Vaginal Speculum.
| Device ID | K130046 |
| 510k Number | K130046 |
| Device Name: | CLEARSPEC SINGLE USE VAGINAL SPECULUM |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | CLEARSPEC LLC 603 GRANT STREET Herkimer, NY 13350 |
| Contact | Ira Duesler |
| Correspondent | Ira Duesler CLEARSPEC LLC 603 GRANT STREET Herkimer, NY 13350 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-08 |
| Decision Date | 2013-08-06 |
| Summary: | summary |