510(k) K771702

VESSEL-STABILIZER by Med General — Product Code KDC

K771702 is an FDA 510(k) premarket notification submitted by Med General for the device "VESSEL-STABILIZER". The FDA issued a decision of Substantially Equivalent on December 13, 1977. The device falls under product code KDC (Instrument, Surgical, Disposable), 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 13, 1977
Date Received
September 8, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type