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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nystagmograph
510(k) Number K820151
Device Name PHILLY INFANT BOLT
Applicant
Philadelphia Medical Specialties
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Philadelphia Medical Specialties
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number882.1460
Classification Product Code
GWN  
Date Received01/19/1982
Decision Date 01/28/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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