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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K942581
Device Name BES - BREATH EXPOSURE SYNCHRONIZER
Applicant
The Henry G. Dietz Co., Inc.
14-26 28th Ave.
Long Island City,  NY  11102
Applicant Contact HENRY G DIETZ
Correspondent
The Henry G. Dietz Co., Inc.
14-26 28th Ave.
Long Island City,  NY  11102
Correspondent Contact HENRY G DIETZ
Regulation Number892.1680
Classification Product Code
KPR  
Date Received05/31/1994
Decision Date 12/12/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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