510(k) K851105

TOOTH EXTRACTING FORCEPS 151(2010)-875 PCS. SS410/ by The Huxley Instrument Corp. — Product Code EMG

K851105 is an FDA 510(k) premarket notification submitted by The Huxley Instrument Corp. for the device "TOOTH EXTRACTING FORCEPS 151(2010)-875 PCS. SS410/". The FDA issued a decision of Substantially Equivalent on May 15, 1985. The device falls under product code EMG (Forceps, Tooth Extractor, Surgical), a Class I device regulated under 21 CFR 872.4565. The Huxley Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1985
Date Received
March 19, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Tooth Extractor, Surgical
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type