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510(k) K913857

ROCATEC(R) -PLUS by Espe GmbH (Us) — Product Code EJH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1991
Date Received
August 27, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Metal, Base
Device Class
Class II
Regulation Number
872.3710
Review Panel
DE
Submission Type

Other clearances by Espe GmbH (Us)

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  • K913966 — SONO(R) -CEM (January 14, 1992)
  • K913965 — ESPE(R) -SIL (December 4, 1991)
  • K905604 — VISIO-GEM ART-SYSTEM (March 29, 1991)
  • K904096 — PHOTAC-BOND (November 19, 1990)
  • K904097 — PHOTAC-BOND APLICAP (November 9, 1990)
  • K904289 — PERTAC UNIVERSAL BOND (November 1, 1990)
  • K900510 — PERTAC-HYBRID (August 9, 1990)
  • K900558 — PERTAC BOND (April 10, 1990)

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  • K030161 — SUPERBOND (March 17, 2003)