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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 K963917
Device Name HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT
Applicant
HOLDEN WALKER CORP.
4227 B ARNOLD AVE.
P.O. BOX 8207
NAPLES,  FL  33941 -8207
Applicant Contact DONALD L RETALLICK, III
Correspondent
HOLDEN WALKER CORP.
4227 B ARNOLD AVE.
P.O. BOX 8207
NAPLES,  FL  33941 -8207
Correspondent Contact DONALD L RETALLICK, III
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/30/1996
Decision Date 02/25/1997
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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