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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Radiographic, Stationary Top
510(k) Number K923775
Device Name R-MADE HEAD/ARM SUPPORT
Applicant
R-Made, Inc.
6689 Orchard Lake Rd.
Unit 197
West Bloomfield,  MI  48322
Applicant Contact JAY M WISEMAN
Correspondent
R-Made, Inc.
6689 Orchard Lake Rd.
Unit 197
West Bloomfield,  MI  48322
Correspondent Contact JAY M WISEMAN
Regulation Number892.1980
Classification Product Code
IXQ  
Date Received07/28/1992
Decision Date 10/20/1992
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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