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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name board, arm (with cover), sterile
510(k) Number K935098
Device Name BABY BOARD
Applicant
SENTRY MEDICAL PRODUCTS, INC.
17171 MURPHY AVE.
IRVINE,  CA  92614 -5915
Applicant Contact JOHN NIELSEN
Correspondent
SENTRY MEDICAL PRODUCTS, INC.
17171 MURPHY AVE.
IRVINE,  CA  92614 -5915
Correspondent Contact JOHN NIELSEN
Regulation Number878.3910
Classification Product Code
BTX  
Date Received10/25/1993
Decision Date 02/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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