510(k) K905573

XEMEX ENTERAL NUTRITION CATHETER NASOGAS. TYPE A by Zeon Medical Corp. — Product Code BSS

K905573 is an FDA 510(k) premarket notification submitted by Zeon Medical Corp. for the device "XEMEX ENTERAL NUTRITION CATHETER NASOGAS. TYPE A". The FDA issued a decision of Substantially Equivalent on June 19, 1991. The device falls under product code BSS (Tube, Nasogastric), a Class II device regulated under 21 CFR 876.5980. Zeon Medical Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1991
Date Received
December 12, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Nasogastric
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type