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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze / Sponge,Nonresorbable For External Use
510(k) Number K946015
Device Name IVALON EXTERNAL SPONGE
Applicant
Ivalon
5374 Linda Vista Rd., Suite C
San Diego,  CA  92110
Applicant Contact ELIZABETH J MELARAGNO
Correspondent
Ivalon
5374 Linda Vista Rd., Suite C
San Diego,  CA  92110
Correspondent Contact ELIZABETH J MELARAGNO
Regulation Number878.4014
Classification Product Code
NAB  
Date Received12/09/1994
Decision Date 02/27/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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