510(k) K061021

ENTAKE STANDARD AND SAFETY PEG SYSTEM by Conmedcorp — Product Code KNT

K061021 is an FDA 510(k) premarket notification submitted by Conmedcorp for the device "ENTAKE STANDARD AND SAFETY PEG SYSTEM". The FDA issued a decision of Substantially Equivalent on April 28, 2006. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Conmedcorp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2006
Date Received
April 13, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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