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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Slide Stainer, Automated
510(k) Number K853210
Device Name MST-1050-II X-RAY UNIT
Applicant
Radiological Engineering, Inc.
2160 Littleton Rd.
North Ft. Myers,  FL  33903
Applicant Contact RALPH L FRIZZLE
Correspondent
Radiological Engineering, Inc.
2160 Littleton Rd.
North Ft. Myers,  FL  33903
Correspondent Contact RALPH L FRIZZLE
Regulation Number864.3800
Classification Product Code
KPA  
Date Received07/31/1985
Decision Date 10/10/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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