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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K972804
Device Name BANG POLYMER GEL DOSIMETER, BANG 533
Applicant
Mgs Research, Inc.
1 Orchard Park Rd., Unit 13
Madison,  CT  06443
Applicant Contact MAREK MARYANSKI
Correspondent
Mgs Research, Inc.
1 Orchard Park Rd., Unit 13
Madison,  CT  06443
Correspondent Contact MAREK MARYANSKI
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/28/1997
Decision Date 10/23/1997
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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