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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 K831148
Device Name HIGH FILTRATION ISO-MASK
Applicant
Tecnol New Jersey Wound Care, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Tecnol New Jersey Wound Care, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4040
Classification Product Code
FXX  
Date Received04/08/1983
Decision Date 07/17/1984
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
Recalls CDRH Recalls
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