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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K890016
Device Name FACE MASK
Applicant
Anjudd Intl.
27068 Lapaz Rd. #435
Laguna Hills,  CA  92656
Applicant Contact JUDY C YUEN
Correspondent
Anjudd Intl.
27068 Lapaz Rd. #435
Laguna Hills,  CA  92656
Correspondent Contact JUDY C YUEN
Regulation Number878.4040
Classification Product Code
FXX  
Date Received01/03/1989
Decision Date 02/03/1989
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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