510(k) K042950
K042950 is an FDA 510(k) premarket notification submitted by Panatrex, Inc. for the device "VAG O SPECULUM, MODELS VS1, VM1, VL1". The FDA issued a decision of Substantially Equivalent on November 30, 2004. The device falls under product code HIB (Speculum, Vaginal, Nonmetal), a Class II device regulated under 21 CFR 884.4530. Panatrex, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 2004
- Date Received
- October 26, 2004
- 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