510(k) K951529
K951529 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "V. MUELLER OBSTETRICAL (OB) FORCEPS". The FDA issued a decision of Substantially Equivalent on August 4, 1995. The device falls under product code HDA (Forceps, Obstetrical), a Class II device regulated under 21 CFR 884.4400. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 1995
- Date Received
- April 3, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, Obstetrical
- Device Class
- Class II
- Regulation Number
- 884.4400
- Review Panel
- OB
- Submission Type