510(k) K910479

ARGYLE POLYURETHANE SALEM SUMP TUBE by Sherwood Medical Co. — Product Code BSS

K910479 is an FDA 510(k) premarket notification submitted by Sherwood Medical Co. for the device "ARGYLE POLYURETHANE SALEM SUMP TUBE". The FDA issued a decision of Substantially Equivalent on April 19, 1991. The device falls under product code BSS (Tube, Nasogastric), a Class II device regulated under 21 CFR 876.5980. Sherwood Medical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1991
Date Received
February 6, 1991
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