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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 K902378
Device Name CARDIOTHORACIC RULER
Applicant
Devcom, Inc.
1700 Russell Rd.
Paoli,  PA  19301
Applicant Contact BRUCE BERLINGER
Correspondent
Devcom, Inc.
1700 Russell Rd.
Paoli,  PA  19301
Correspondent Contact BRUCE BERLINGER
Regulation Number892.1680
Classification Product Code
KPR  
Date Received05/29/1990
Decision Date 06/14/1990
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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