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510(k) K951272

RELACS 7000 by Micro-Mega Societe Anonyme — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1995
Date Received
March 21, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scaler, Ultrasonic
Device Class
Class II
Regulation Number
872.4850
Review Panel
DE
Submission Type

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  • K961494 — SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE (June 26, 1996)
  • K961076 — MM 324 (April 26, 1996)
  • K950555 — J SINGLE USE HEAD AND JD REUSABLE HANDLE (December 28, 1995)

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