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510(k) K963843

ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT by Micro Motors, Inc. — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1997
Date Received
September 25, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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  • K896878 — HANDPIECE SYSTEM WITH MOTOR (SEVERAL MODELS) (March 8, 1990)
  • K896879 — ORAL SURGERY HANDPIECE AND ATTACHMENTS (March 7, 1990)

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