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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Balloon, Epistaxis
510(k) Number K896248
Device Name INNOVATIONS NASAL TAMPON
Applicant
Innovations by Necessity, Inc.
3334 E. Coast Hwy.,
Suite 128
Corona Del Mar,  CA  92625
Applicant Contact KAREN BENDT
Correspondent
Innovations by Necessity, Inc.
3334 E. Coast Hwy.,
Suite 128
Corona Del Mar,  CA  92625
Correspondent Contact KAREN BENDT
Regulation Number874.4100
Classification Product Code
EMX  
Date Received10/30/1989
Decision Date 04/13/1990
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
Predetermined Change
Control Plan Authorized		 No
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