510(k) K884127

LAKE N/G FEEDING TUBE by Lake Medical Products, Inc. — Product Code KNT

K884127 is an FDA 510(k) premarket notification submitted by Lake Medical Products, Inc. for the device "LAKE N/G FEEDING TUBE". The FDA issued a decision of Substantially Equivalent on February 8, 1989. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Lake Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 1989
Date Received
September 30, 1988
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