The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Kleenspec Single Use Vaginal Speculum And 790 Series Cordless Illumination System.
| Device ID | K070964 |
| 510k Number | K070964 |
| Device Name: | KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | WELCH ALLYN, INC. 4341 STATE STREET ROAD PO BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | Chris Horacek |
| Correspondent | Chris Horacek WELCH ALLYN, INC. 4341 STATE STREET ROAD PO BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-05 |
| Decision Date | 2007-05-18 |
| Summary: | summary |