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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, Pneumatic
510(k) Number K931876
Device Name FISK ARM SUPPORT
Applicant
Vvortex International Corp.
11321 Trade Center Dr.,
Suite 260
Rancho Cordova,  CA  95742
Applicant Contact SHANE FISK
Correspondent
Vvortex International Corp.
11321 Trade Center Dr.,
Suite 260
Rancho Cordova,  CA  95742
Correspondent Contact SHANE FISK
Regulation Number878.4960
Classification Product Code
FWW  
Date Received04/14/1993
Decision Date 09/09/1993
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
Predetermined Change
Control Plan Authorized		 No
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