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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 K926291
Device Name SCHUL-TEC IMMOBILIZER
Applicant
Medical Emergency Support Equipment
1642 Forest Hills Dr.
St. Charles,  MO  63303
Applicant Contact GREGG R SCHULTE
Correspondent
Medical Emergency Support Equipment
1642 Forest Hills Dr.
St. Charles,  MO  63303
Correspondent Contact GREGG R SCHULTE
Regulation Number890.3490
Classification Product Code
IQK  
Date Received12/14/1992
Decision Date 03/30/1993
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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