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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 K963924
Device Name LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70
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 Received09/30/1996
Decision Date 12/10/1996
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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