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510(k) K983105

CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE HOLDER (REPLACEMENTS), MODEL # CCS-100-01 by Dentsply Midwest — Product Code EJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1999
Date Received
September 4, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Cartridge
Device Class
Class II
Regulation Number
872.6770
Review Panel
DE
Submission Type

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