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510(k) K031540

APEX ELECTRIC HANDPIECE SYSTEM by Lares Research, Inc. — Product Code EKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2003
Date Received
May 16, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Handpiece, Direct Drive, Ac-Powered
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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  • K961163 — LARES RESEARCH AS-1 LOWSPEED HANDPIECE (April 23, 1996)
  • K905543 — LARES APOLLO CS/CP/C (March 11, 1991)
  • K905542 — LARES APOLLO CS AND S HANDPIECE LIGHTING SYSTEMS (March 11, 1991)
  • K905541 — LARES 757 WORKHORSE HIGHSPEED HANDPIECE (March 7, 1991)

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