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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Operating-Room, Ac-Powered
510(k) Number K921143
Device Name PNEUMO-WEDGE
Applicant
KANSAS CREATIVE DEVICES, INC.
11835 ROE AVE.
SUITE 107
LAEWOOD,  KS  66211
Applicant Contact JEFFREY S HOWELL
Correspondent
KANSAS CREATIVE DEVICES, INC.
11835 ROE AVE.
SUITE 107
LAEWOOD,  KS  66211
Correspondent Contact JEFFREY S HOWELL
Regulation Number878.4960
Classification Product Code
FQO  
Date Received03/11/1992
Decision Date 09/11/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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