510(k) K760605

LIGHTCAST II CARBIDE BLADE by Merck, Sharp & Dohme — Product Code GES

K760605 is an FDA 510(k) premarket notification submitted by Merck, Sharp & Dohme for the device "LIGHTCAST II CARBIDE BLADE". The FDA issued a decision of Substantially Equivalent on October 5, 1976. The device falls under product code GES (Blade, Scalpel), a Class I device regulated under 21 CFR 878.4800. Merck, Sharp & Dohme has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1976
Date Received
September 8, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Blade, Scalpel
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type