510(k) K010797

RUSCH MILLER-ABBOTT TUBE by Rusch Intl. — Product Code KNT

K010797 is an FDA 510(k) premarket notification submitted by Rusch Intl. for the device "RUSCH MILLER-ABBOTT TUBE". The FDA issued a decision of Substantially Equivalent on February 26, 2002. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Rusch Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2002
Date Received
March 16, 2001
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