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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K903346
Device Name DISPOSABLE EMISSIONS BARRIER LASER DRAPE
Applicant
Wave-Form Systems, Inc.
P.O. Box 3195
Portland,  OR  97208
Applicant Contact CHARLES R WATKINS
Correspondent
Wave-Form Systems, Inc.
P.O. Box 3195
Portland,  OR  97208
Correspondent Contact CHARLES R WATKINS
Regulation Number878.4370
Classification Product Code
KKX  
Date Received07/25/1990
Decision Date 12/05/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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