510(k) K875126

MIC (SPECIFIC LINE) INSERTION KIT by Medical Innovations Corp. — Product Code KNT

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
March 2, 1988
Date Received
December 15, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type