DISPOSABLE COLOR-CUFFS

Tourniquet, Pneumatic

INSTRUMED, INC.

The following data is part of a premarket notification filed by Instrumed, Inc. with the FDA for Disposable Color-cuffs.

Pre-market Notification Details

Device IDK890014
510k NumberK890014
Device Name:DISPOSABLE COLOR-CUFFS
ClassificationTourniquet, Pneumatic
Applicant INSTRUMED, INC. 12911 NE 126TH PL. Kirkland,  WA  98034
ContactJerry L Spence
CorrespondentJerry L Spence
INSTRUMED, INC. 12911 NE 126TH PL. Kirkland,  WA  98034
Product CodeKCY  
CFR Regulation Number878.5910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-01-03
Decision Date1989-01-24

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