510(k) K782006

MEDGENERAL SINGLE-USE BULLDOG by Med General — Product Code GDJ

K782006 is an FDA 510(k) premarket notification submitted by Med General for the device "MEDGENERAL SINGLE-USE BULLDOG". The FDA issued a decision of Substantially Equivalent on December 15, 1978. The device falls under product code GDJ (Clamp, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Med General has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1978
Date Received
December 1, 1978
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