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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 K953697
Device Name THE IMS DPAP MASK, IMS MODEL NUMBER 82000
Applicant
SLEEPNET CORPORATION
1050 PERIMETER RD.
LOCKHEED AIR CENTER
MANCHESTER,  NH  03103
Applicant Contact RITA M WADLEIGH
Correspondent
SLEEPNET CORPORATION
1050 PERIMETER RD.
LOCKHEED AIR CENTER
MANCHESTER,  NH  03103
Correspondent Contact RITA M WADLEIGH
Regulation Number868.5905
Classification Product Code
BZD  
Date Received08/08/1995
Decision Date 06/13/1996
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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