510(k) K831539

ECONOMY PLASTIC SOCK-BK2084-AID by Fred Sammons, Inc. — Product Code ILD

K831539 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "ECONOMY PLASTIC SOCK-BK2084-AID". The FDA issued a decision of Substantially Equivalent on June 8, 1983. The device falls under product code ILD (Adaptor, Dressing), a Class I device regulated under 21 CFR 890.5050. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1983
Date Received
May 12, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adaptor, Dressing
Device Class
Class I
Regulation Number
890.5050
Review Panel
PM
Submission Type