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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K970128
Device Name ISOCAM I (SINGLE HEAD GAMMA CAMERA)/ISOCAM II (DUAL HEAD GAMMA CAMERA)
Applicant
Park Medical Systems, Inc.
3195 Louis A Amos
Lachine Quebec,  CA H8T 1C4
Applicant Contact PETER SCHULTZ
Correspondent
Park Medical Systems, Inc.
3195 Louis A Amos
Lachine Quebec,  CA H8T 1C4
Correspondent Contact PETER SCHULTZ
Regulation Number892.1200
Classification Product Code
KPS  
Date Received01/14/1997
Decision Date 04/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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