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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spirometer, therapeutic (incentive)
510(k) Number K972042
Device Name PARI PEP THERAPY SYSTEM
Applicant
PARI HOLDING CO.
13800 HULL ST. RD.
MIDLOTHIAN,  VA  23112
Applicant Contact MIGUEL A ARRIZON
Correspondent
PARI HOLDING CO.
13800 HULL ST. RD.
MIDLOTHIAN,  VA  23112
Correspondent Contact MIGUEL A ARRIZON
Regulation Number868.5690
Classification Product Code
BWF  
Date Received06/02/1997
Decision Date 08/05/1997
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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