510(k) K873954

NAMIC HAWKINS UNIVERSAL DRAINAGE SET by North American Instrument Corp. — Product Code FGE

K873954 is an FDA 510(k) premarket notification submitted by North American Instrument Corp. for the device "NAMIC HAWKINS UNIVERSAL DRAINAGE SET". The FDA issued a decision of Substantially Equivalent on January 29, 1988. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. North American Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1988
Date Received
September 28, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stents, Drains And Dilators For The Biliary Ducts
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type