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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respirator, Surgical
510(k) Number K974068
Device Name PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL
Applicant
TECNOL MEDICAL PRODUCTS, INC.
7201 INDUSTRIAL PARK BLVD.
FORT WORTH,  TX  76180
Applicant Contact RUTH JONES
Correspondent
TECNOL MEDICAL PRODUCTS, INC.
7201 INDUSTRIAL PARK BLVD.
FORT WORTH,  TX  76180
Correspondent Contact RUTH JONES
Regulation Number878.4040
Classification Product Code
MSH  
Date Received10/28/1997
Decision Date 12/22/1997
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
Recalls CDRH Recalls
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