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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Liner, Cavity, Calcium Hydroxide
510(k) Number K905723
Device Name IONOSEAL
Applicant
Micro-Vac, Inc.
4132 E. Speedway Blvd.
Tucson,  AZ  85712
Applicant Contact CHERYL L HENDERSON
Correspondent
Micro-Vac, Inc.
4132 E. Speedway Blvd.
Tucson,  AZ  85712
Correspondent Contact CHERYL L HENDERSON
Regulation Number872.3250
Classification Product Code
EJK  
Date Received12/20/1990
Decision Date 03/15/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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