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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 K123115
Device Name ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P
Applicant
Acme Filter Mask, Inc.
# 57 Hu Shan Rd.
Yingge District
New Taipei City,  TW 23941
Applicant Contact JEN KE-MIN
Correspondent
Acme Filter Mask, Inc.
# 57 Hu Shan Rd.
Yingge District
New Taipei City,  TW 23941
Correspondent Contact JEN KE-MIN
Regulation Number878.4040
Classification Product Code
FXX  
Date Received10/03/2012
Decision Date 05/20/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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