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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 K832194
Device Name SURGICAL FACE MASK-DISPOSABLE
Applicant
Tecnol New Jersey Wound Care, Inc.
368 Fairview Ave.
Hammonton,  NJ  08037
Correspondent
Tecnol New Jersey Wound Care, Inc.
368 Fairview Ave.
Hammonton,  NJ  08037
Regulation Number878.4040
Classification Product Code
FXX  
Date Received07/08/1983
Decision Date 07/26/1983
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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