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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 K862016
Device Name PACH-PEN SURGICAL DRAPE
Applicant
Oculab, Inc.
443 W. Colorado St.
Glendale,  CA  91205
Applicant Contact WALLACE, M.D.
Correspondent
Oculab, Inc.
443 W. Colorado St.
Glendale,  CA  91205
Correspondent Contact WALLACE, M.D.
Regulation Number878.4370
Classification Product Code
KKX  
Date Received05/28/1986
Decision Date 06/04/1986
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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