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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Remote-Controlled
510(k) Number K943109
Device Name REMOTE CONTROL RADIOISOTOPE APPLICATOR
Applicant
Inter-Pal GmbH
2228 Via La Brea
Palos Verdes Estates,  CA  90274
Applicant Contact AJMEL PUTHAWALA
Correspondent
Inter-Pal GmbH
2228 Via La Brea
Palos Verdes Estates,  CA  90274
Correspondent Contact AJMEL PUTHAWALA
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received06/29/1994
Decision Date 02/09/1995
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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