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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K974453
Device Name NASAL INTERFACE MODEL 7910
Applicant
Healthdyne Technologies, Inc.
1255 Kennestone Cir.
Marietta,  GA  30066
Applicant Contact BETTY CORTELLONI
Correspondent
Healthdyne Technologies, Inc.
1255 Kennestone Cir.
Marietta,  GA  30066
Correspondent Contact BETTY CORTELLONI
Regulation Number868.5905
Classification Product Code
BZD  
Date Received11/25/1997
Decision Date 08/04/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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