510(k) K932880

GRASSI GASTROJEJUNOSTOMY TUBE by Bissell Medical Products, Inc. — Product Code KNT

K932880 is an FDA 510(k) premarket notification submitted by Bissell Medical Products, Inc. for the device "GRASSI GASTROJEJUNOSTOMY TUBE". The FDA issued a decision of Substantially Equivalent on June 7, 1995. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Bissell Medical Products, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1995
Date Received
June 14, 1993
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