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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Uptake, Nuclear
510(k) Number K961321
Device Name GAMMA GUIDANCE SYSTEM
Applicant
Radiation Monitoring Devices, Inc.
44 Hunt St.
Watertown,  MA  02472 -4699
Applicant Contact PAUL STOPPEL
Correspondent
Radiation Monitoring Devices, Inc.
44 Hunt St.
Watertown,  MA  02472 -4699
Correspondent Contact PAUL STOPPEL
Regulation Number892.1320
Classification Product Code
IZD  
Date Received04/05/1996
Decision Date 02/10/1997
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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