510(k) K801713

BK-6157-02 C.V.A SLING, MEDIUM&LARGE by Fred Sammons, Inc. — Product Code ILI

K801713 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "BK-6157-02 C.V.A SLING, MEDIUM&LARGE". The FDA issued a decision of Substantially Equivalent on August 7, 1980. The device falls under product code ILI (Sling, Arm), a Class I device regulated under 21 CFR 890.3640. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1980
Date Received
July 24, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sling, Arm
Device Class
Class I
Regulation Number
890.3640
Review Panel
PM
Submission Type