KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM— 510(k) K070964
Substantially EquivalentWelch Allyn, Inc.
FDA 510(k) clearance K070964 for KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM, Substantially Equivalent on 2007-05-18. Applicant: Welch Allyn, Inc.. Device class: 2.
Clearance details
- Applicant
- Welch Allyn, Inc.
- Product code
- Code HIB
- Device class
- Class 2
- Regulation
- 21 CFR 884.4530
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Skaneateles Falls, NY, US
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