510(k) K922659

GENERAL SURGERY CLAMP AND NEEDLE HOLDER by Miltex Instrument Co. — Product Code GDJ

K922659 is an FDA 510(k) premarket notification submitted by Miltex Instrument Co. for the device "GENERAL SURGERY CLAMP AND NEEDLE HOLDER". The FDA issued a decision of Substantially Equivalent on July 21, 1992. The device falls under product code GDJ (Clamp, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Miltex Instrument Co. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1992
Date Received
June 3, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type