510(k) K880046

HASTING FINGER FIXATOR INSTRUMENTS by Buckman Co., Inc. — Product Code HXY

K880046 is an FDA 510(k) premarket notification submitted by Buckman Co., Inc. for the device "HASTING FINGER FIXATOR INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on February 16, 1988. The device falls under product code HXY (Brace, Drill), a Class I device regulated under 21 CFR 888.4540. Buckman Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1988
Date Received
January 6, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Brace, Drill
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type