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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 K964113
Device Name IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL
Applicant
M-PACT WORLDWIDE MANAGEMENT CORP.
1040 OCL PKWY.
P.O. BOX 618
EUDORA,  KS  66025
Applicant Contact MARY SCHMALZ
Correspondent
M-PACT WORLDWIDE MANAGEMENT CORP.
1040 OCL PKWY.
P.O. BOX 618
EUDORA,  KS  66025
Correspondent Contact MARY SCHMALZ
Regulation Number874.4100
Classification Product Code
EMX  
Date Received10/15/1996
Decision Date 11/07/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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