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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 K950206
Device Name FISONEB(R) II
Applicant
FISONS CORP.
JEFFERSON RD.
P.O. BOX 1710
ROCHESTER,  NY  14603
Applicant Contact JOAN M WOODCOOK
Correspondent
FISONS CORP.
JEFFERSON RD.
P.O. BOX 1710
ROCHESTER,  NY  14603
Correspondent Contact JOAN M WOODCOOK
Regulation Number868.5630
Classification Product Code
CAF  
Date Received01/18/1995
Decision Date 01/27/1995
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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