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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, emergency, powered (resuscitator)
510(k) Number K960515
Device Name PARAPAC
Applicant
PNEU PAC, LTD.
CRESCENT RD.
LUTON BEDS LU2 OAH,  GB
Applicant Contact NORMAN S JONES, PH.D.
Correspondent
PNEU PAC, LTD.
CRESCENT RD.
LUTON BEDS LU2 OAH,  GB
Correspondent Contact NORMAN S JONES, PH.D.
Regulation Number868.5925
Classification Product Code
BTL  
Date Received02/05/1996
Decision Date 10/10/1996
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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