510(k) K873441

BAKER TWIN-CUFF INTESTINAL DECOMP/PLICATION TUBE by Bissell Medical Products, Inc. — Product Code KNT

K873441 is an FDA 510(k) premarket notification submitted by Bissell Medical Products, Inc. for the device "BAKER TWIN-CUFF INTESTINAL DECOMP/PLICATION TUBE". The FDA issued a decision of Substantially Equivalent on October 27, 1987. 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
October 27, 1987
Date Received
August 27, 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