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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K853428
Device Name CPR PROMPT
Applicant
Hutchins Tool & Engineering Co., Inc.
Burditt, Bowles & Radzius
1029 Vermont Ave. #400
Washington,  DC  20005
Applicant Contact EUGENE PFEIFER
Correspondent
Hutchins Tool & Engineering Co., Inc.
Burditt, Bowles & Radzius
1029 Vermont Ave. #400
Washington,  DC  20005
Correspondent Contact EUGENE PFEIFER
Date Received08/15/1985
Decision Date 09/06/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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