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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Communication, Non-Powered
510(k) Number K810452
Device Name NON-POWERED COMMUNICATION SYSTEMS
Applicant
Fred Sammons, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Fred Sammons, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.3700
Classification Product Code
ILP  
Date Received02/19/1981
Decision Date 03/04/1981
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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