510(k) K863686

BACK REST, LITTER, NON-ADJUSTABLE by Brenner Metal Prod Corp. — Product Code FPP

K863686 is an FDA 510(k) premarket notification submitted by Brenner Metal Prod Corp. for the device "BACK REST, LITTER, NON-ADJUSTABLE". The FDA issued a decision of Substantially Equivalent on January 20, 1987. The device falls under product code FPP (Stretcher, Hand-Carried), a Class I device regulated under 21 CFR 880.6900. Brenner Metal Prod Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 1987
Date Received
September 19, 1986
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