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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 K851396
Device Name SANDER'S MASKCPAP BY RESPIRONICS
Applicant
Respironics, Inc.
530 Seco Rd.
Monroeville,  PA  15146
Applicant Contact EUGENE N SCARBERRY
Correspondent
Respironics, Inc.
530 Seco Rd.
Monroeville,  PA  15146
Correspondent Contact EUGENE N SCARBERRY
Regulation Number868.5965
Classification Product Code
BYE  
Date Received04/09/1985
Decision Date 05/15/1985
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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