510(k) K922816

U P CUSTOM DESIGN, INC. COT EQUIPMENT CARRIER by Up Custom Design, Inc. — Product Code FPP

K922816 is an FDA 510(k) premarket notification submitted by Up Custom Design, Inc. for the device "U P CUSTOM DESIGN, INC. COT EQUIPMENT CARRIER". The FDA issued a decision of Substantially Equivalent on July 13, 1993. The device falls under product code FPP (Stretcher, Hand-Carried), a Class I device regulated under 21 CFR 880.6900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1993
Date Received
June 11, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stretcher, Hand-Carried
Device Class
Class I
Regulation Number
880.6900
Review Panel
HO
Submission Type