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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Cartridge
510(k) Number K083796
Device Name MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT
Applicant
Miltex, Inc.
589 Davies Dr.
York,  PA  17402
Applicant Contact JENNIFER J BOSLEY
Correspondent
Miltex, Inc.
589 Davies Dr.
York,  PA  17402
Correspondent Contact JENNIFER J BOSLEY
Regulation Number872.6770
Classification Product Code
EJI  
Date Received12/22/2008
Decision Date 03/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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