510(k) K855144

TOURIQUET KIT WITH SNARE by Dlp, Inc. — Product Code GDJ

K855144 is an FDA 510(k) premarket notification submitted by Dlp, Inc. for the device "TOURIQUET KIT WITH SNARE". The FDA issued a decision of Substantially Equivalent on February 5, 1986. The device falls under product code GDJ (Clamp, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Dlp, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1986
Date Received
December 26, 1985
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