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510(k) K843901

ISOSTATIC CONDENSER by Shofu Dental Corp. — Product Code EKG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1984
Date Received
October 3, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condenser, Amalgam And Foil, Operative
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

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Other clearances for product code EKG

  • K865025 — AUSTENAL CONDENSING INSTRUMENT (February 19, 1987)
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