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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table And Attachments, Operating-Room
510(k) Number K942699
Device Name AIRFRAME SURGICAL DRAPE SUPPORT
Applicant
ALPHA SURGICAL, INC.
2116 ANDREW DR.
EAU CLAIRE,  WI  54701
Applicant Contact TIMOTHY J JUNTUNEN
Correspondent
ALPHA SURGICAL, INC.
2116 ANDREW DR.
EAU CLAIRE,  WI  54701
Correspondent Contact TIMOTHY J JUNTUNEN
Regulation Number878.4950
Classification Product Code
BWN  
Date Received06/08/1994
Decision Date 07/13/1994
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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