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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Compressor, Air, Portable
510(k) Number K002862
Device Name PRONEB ULTRA MODEL NUMBER 85B0100
Applicant
PARI HOLDING CO.
13800 HULL ST. RD.
MIDLOTHIAN,  VA  23112
Applicant Contact DEBRA A PEKAR
Correspondent
PARI HOLDING CO.
13800 HULL ST. RD.
MIDLOTHIAN,  VA  23112
Correspondent Contact DEBRA A PEKAR
Regulation Number868.6250
Classification Product Code
BTI  
Date Received09/13/2000
Decision Date 03/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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