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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 K970448
Device Name PCM 2000; ISOLAIR APR MODEL 2735
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 Received02/06/1997
Decision Date 04/30/1997
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
Predetermined Change
Control Plan Authorized		 No
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