510(k) K052192
K052192 is an FDA 510(k) premarket notification submitted by Femspec LLC for the device "FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I". The FDA issued a decision of Substantially Equivalent on February 2, 2006. The device falls under product code HIB (Speculum, Vaginal, Nonmetal), a Class II device regulated under 21 CFR 884.4530. Femspec LLC has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 2, 2006
- Date Received
- August 11, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Speculum, Vaginal, Nonmetal
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type