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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Attachment, Breathing, Positive End Expiratory Pressure
510(k) Number K953511
Device Name KENDALL SHERIDAN CPAP SYSTEM
Applicant
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Applicant Contact DAVID A OLSON
Correspondent
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Correspondent Contact DAVID A OLSON
Regulation Number868.5965
Classification Product Code
BYE  
Date Received07/26/1995
Decision Date 10/26/1995
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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