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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nebulizer (direct patient interface)
510(k) Number K962072
Device Name PRONEB TURBO COMPRESSOR MODEL 38V0200
Applicant
PARI HOLDING CO.
7493 WHITEPINE RD.
RICHMOND,  VA  23237
Applicant Contact MIGUEL A ARRIZON
Correspondent
PARI HOLDING CO.
7493 WHITEPINE RD.
RICHMOND,  VA  23237
Correspondent Contact MIGUEL A ARRIZON
Regulation Number868.5630
Classification Product Code
CAF  
Date Received05/28/1996
Decision Date 08/21/1996
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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