510(k) K851883
K851883 is an FDA 510(k) premarket notification submitted by The Huxley Instrument Corp. for the device "SIMPSON OBSTETRICAL FORCEPS-SS TYPE 410 OR 420". The FDA issued a decision of Substantially Equivalent on May 9, 1985. The device falls under product code HDA (Forceps, Obstetrical), a Class II device regulated under 21 CFR 884.4400. The Huxley Instrument Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 1985
- Date Received
- April 29, 1985
- 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