510(k) K851883

SIMPSON OBSTETRICAL FORCEPS-SS TYPE 410 OR 420 by The Huxley Instrument Corp. — Product Code HDA

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