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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Feeding
510(k) Number K852100
Device Name THE HENLEY BOARD S.I.D. SPINAL IMMOBILIZATION DEVI
Applicant
Henley Board, Inc.
213 Crabb Ave.
Rockville,  MD  20850
Applicant Contact A.F.(JAY) HENLEY
Correspondent
Henley Board, Inc.
213 Crabb Ave.
Rockville,  MD  20850
Correspondent Contact A.F.(JAY) HENLEY
Regulation Number876.5980
Classification Product Code
FPD  
Date Received05/15/1985
Decision Date 07/24/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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