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510(k) K012156

IMAGINE H.E. by Wieland Edelmetalle GmbH & Co. — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2001
Date Received
July 11, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powder, Porcelain
Device Class
Class II
Regulation Number
872.6660
Review Panel
DE
Submission Type

Other clearances by Wieland Edelmetalle GmbH & Co.

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  • K012841 — DUO PAL 6, ORDER-NO.: 2154 (November 20, 2001)
  • K012843 — PORTADUR P 2, MODEL #2031 (November 2, 2001)
  • K012828 — PORTA SMK 82, MODEL 2032 (November 1, 2001)
  • K012834 — PORTA GEO TI MODEL #2004 (November 1, 2001)
  • K012826 — BIOPORTA G, MODEL 2052 (November 1, 2001)
  • K012831 — BIO PORTADUR, ORDER-NO.:2017 (November 1, 2001)
  • K012827 — PORTA AURIUM, MODEL 2067 (November 1, 2001)
  • K012835 — PORTA MAXIMUM, MODEL# 2066 (November 1, 2001)

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