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510(k) K850666

STROBEX ULTRON ELECTROSURGE-DENTAL UNIT by Ipco Corp. — Product Code EKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1985
Date Received
February 20, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, And Accessories, Dental
Device Class
Class II
Regulation Number
872.4920
Review Panel
DE
Submission Type

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  • K840754 — MAXISHIELD INCONTINENCE CARE SYSTEM (April 13, 1984)
  • K800292 — ENDEX BROACH, ENDODONTIC (February 19, 1980)

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