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510(k) K892937

REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS by Dentsply Intl. — Product Code JDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1989
Date Received
April 21, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mixer, Cement, For Clinical Use
Device Class
Class I
Regulation Number
888.4210
Review Panel
OR
Submission Type

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Other clearances for product code JDZ

  • K934253 — EXACTECH ALL POLY ACETABULAR CUP (April 29, 1994)
  • K925025 — PRISM BONE CEMENT MIXING SYSTEM (January 5, 1994)
  • K912190 — STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST (August 29, 1991)
  • K861086 — ZIMMER VACUUM MIXING SYSTEM (April 14, 1986)
  • K854077 — MIX EVAC II (January 31, 1986)
  • K853310 — SIMPLEX ENHANCEMENT MIXER (September 11, 1985)
  • K851205 — CEMENTRIFUGE (July 16, 1985)
  • K843219 — ZIMMER BONE CEMENT CENTRIFUGATION SYS (November 29, 1984)
  • K792186 — HOWMEDICA MIX-KIT II (December 5, 1979)
  • K780857 — MIXING BOWL & SPATULA, DISPOSABLE (June 13, 1978)