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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chamber, Patient Isolation
510(k) Number K884295
Device Name SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE
Applicant
Saybrex Intl., Inc.
215 1/2 S. Arnaz Dr.
Beverly Hills,  CA  90211
Applicant Contact JOSEPH BUSSEL
Correspondent
Saybrex Intl., Inc.
215 1/2 S. Arnaz Dr.
Beverly Hills,  CA  90211
Correspondent Contact JOSEPH BUSSEL
Regulation Number880.5450
Classification Product Code
LGM  
Date Received10/12/1988
Decision Date 11/08/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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