510(k) K904511

HAND-CARRIED STRETCHERS/BREAK AWAY FLAT by Minto Research & Development, Inc. — Product Code FPP

K904511 is an FDA 510(k) premarket notification submitted by Minto Research & Development, Inc. for the device "HAND-CARRIED STRETCHERS/BREAK AWAY FLAT". The FDA issued a decision of Substantially Equivalent on October 12, 1990. The device falls under product code FPP (Stretcher, Hand-Carried), a Class I device regulated under 21 CFR 880.6900. Minto Research & Development, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 1990
Date Received
October 2, 1990
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