510(k) K881516

COMPRESAID by R. Evans Corp. — Product Code FZF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1988
Date Received
April 11, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Extremity, Inflatable, External
Device Class
Class I
Regulation Number
878.3900
Review Panel
SU
Submission Type