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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name humidifier, respiratory gas, (direct patient interface)
510(k) Number K963025
Device Name SLEEPNET HUMIDIFIER,(84200 PACKAGED)
Applicant
SLEEPNET CORPORATION
1050 PERIMETER RD.,
LOCKHEED AIR CENTER
MANCHESTER,  NH  03103
Applicant Contact THOMAS E ASACKER
Correspondent
SLEEPNET CORPORATION
1050 PERIMETER RD.,
LOCKHEED AIR CENTER
MANCHESTER,  NH  03103
Correspondent Contact THOMAS E ASACKER
Regulation Number868.5450
Classification Product Code
BTT  
Date Received08/05/1996
Decision Date 11/01/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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