510(k) K852713

RUSSIAN TISSUE FORCEPS, 6 + SS 410 OR 420 by The Huxley Instrument Corp. — Product Code HTD

K852713 is an FDA 510(k) premarket notification submitted by The Huxley Instrument Corp. for the device "RUSSIAN TISSUE FORCEPS, 6 + SS 410 OR 420". The FDA issued a decision of Substantially Equivalent on July 15, 1985. The device falls under product code HTD (Forceps), a Class I device regulated under 21 CFR 878.4800. The Huxley Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1985
Date Received
June 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type