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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 K881833
Device Name NASAL CPAP SYSTEM
Applicant
Healthdyne, Inc.
1850 Pkwy. Pl., 12th Floor
Marietta,  GA  30067
Applicant Contact TIM COWART
Correspondent
Healthdyne, Inc.
1850 Pkwy. Pl., 12th Floor
Marietta,  GA  30067
Correspondent Contact TIM COWART
Regulation Number868.5965
Classification Product Code
BYE  
Date Received04/29/1988
Decision Date 06/24/1988
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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