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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Cervical
510(k) Number K930730
Device Name DORMIE NECK SUPPORT SYSTEM
Applicant
The Western Diagnostics Co.
2617a Okeechobee Blvd.
West Palm Beach,  FL  33409
Applicant Contact ERIC S SIEGEL
Correspondent
The Western Diagnostics Co.
2617a Okeechobee Blvd.
West Palm Beach,  FL  33409
Correspondent Contact ERIC S SIEGEL
Regulation Number890.3490
Classification Product Code
IQK  
Date Received02/11/1993
Decision Date 07/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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