510(k) K841986

PROTOMED/TOWIC NASOGASTRIC TUBE DRAINAGE BAG by Protomed Corp. — Product Code KNT

K841986 is an FDA 510(k) premarket notification submitted by Protomed Corp. for the device "PROTOMED/TOWIC NASOGASTRIC TUBE DRAINAGE BAG". The FDA issued a decision of Substantially Equivalent on September 10, 1984. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Protomed Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1984
Date Received
May 15, 1984
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