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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 K904112
Device Name STI DRAPE SHEET STYLE 1908
Applicant
Sterilizer Technologies Corp.
Rd. 701 Km. 0.7
Salinas Industrial Park
Salinas, Puerto Rico, 
Applicant Contact JORGE A VIVONI
Correspondent
Sterilizer Technologies Corp.
Rd. 701 Km. 0.7
Salinas Industrial Park
Salinas, Puerto Rico, 
Correspondent Contact JORGE A VIVONI
Regulation Number878.4370
Classification Product Code
KKX  
Date Received09/06/1990
Decision Date 10/30/1990
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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