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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accessory to continuous ventilator (respirator)
510(k) Number K091461
Device Name BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE
Applicant
CARDIOPULMONARY CORP.
200 CASCADE BLVD.
MILFORD,  CT  06460
Applicant Contact JORDAN SCHRECK
Correspondent
CARDIOPULMONARY CORP.
200 CASCADE BLVD.
MILFORD,  CT  06460
Correspondent Contact JORDAN SCHRECK
Regulation Number868.5895
Classification Product Code
MOD  
Subsequent Product Code
MSX  
Date Received05/18/2009
Decision Date 08/14/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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