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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 K880613
Device Name ACCO(R) FACE MASK
Applicant
Absorbent Cotton Co., Inc.
P.O. Box 268
368 Fairview Ave.
Hammonton,  NJ  08037
Applicant Contact PATRICK J LAMB
Correspondent
Absorbent Cotton Co., Inc.
P.O. Box 268
368 Fairview Ave.
Hammonton,  NJ  08037
Correspondent Contact PATRICK J LAMB
Regulation Number878.4040
Classification Product Code
FXX  
Date Received02/16/1988
Decision Date 03/04/1988
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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