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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
Predetermined Change
Control Plan Authorized		 No
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