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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dilator, nasal
510(k) Number K962400
Device Name AIR MAX EXTERNAL NASAL DILATOR STRIP
Applicant
AMERICAN WHITE CROSS, INC.
349 LAKE RD.
P.O. BOX 419
DAYVILLE,  CT  06241
Applicant Contact PAUL B CALLAHAN
Correspondent
AMERICAN WHITE CROSS, INC.
349 LAKE RD.
P.O. BOX 419
DAYVILLE,  CT  06241
Correspondent Contact PAUL B CALLAHAN
Regulation Number874.3900
Classification Product Code
LWF  
Date Received06/21/1996
Decision Date 09/09/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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