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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 K871693
Device Name SLEEP APNEA NASAL CPAP SYSTEM
Applicant
Puritan Bennett Corp.
9401 Indian Creek Pkwy.
P.O. Box 25905
Overland Park,  KS  66225
Applicant Contact HARTLEY C ERICSON
Correspondent
Puritan Bennett Corp.
9401 Indian Creek Pkwy.
P.O. Box 25905
Overland Park,  KS  66225
Correspondent Contact HARTLEY C ERICSON
Regulation Number868.5965
Classification Product Code
BYE  
Date Received04/29/1987
Decision Date 09/15/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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