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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 K904873
Device Name STERILE SURGICAL PACK
Applicant
Angelica Healthcare Services
300 Ranger St.
Brea,  CA  92621
Applicant Contact MICHAEL ZOZAYA
Correspondent
Angelica Healthcare Services
300 Ranger St.
Brea,  CA  92621
Correspondent Contact MICHAEL ZOZAYA
Regulation Number878.4370
Classification Product Code
KKX  
Date Received10/30/1990
Decision Date 08/29/1991
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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