510(k) K852726

ALLIS TISSUE FORCEPS, 4X5 TEETH, 6+SS 410 OR 420 by The Huxley Instrument Corp. — Product Code KOA

K852726 is an FDA 510(k) premarket notification submitted by The Huxley Instrument Corp. for the device "ALLIS TISSUE FORCEPS, 4X5 TEETH, 6+SS 410 OR 420". The FDA issued a decision of Substantially Equivalent on July 9, 1985. The device falls under product code KOA (Surgical Instruments, G-U, Manual (And Accessories)), a Class I device regulated under 21 CFR 876.4730. The Huxley Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1985
Date Received
June 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Surgical Instruments, G-U, Manual (And Accessories)
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type