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510(k) K922837

S1500 XENON LIGHT SOURCE by Endomedix — Product Code HBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1992
Date Received
June 12, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Illuminator, Fiberoptic, Surgical Field
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

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  • K930349 — STONE RETRIEVAL BASKET (June 9, 1993)
  • K926004 — ENDOSCOPE AND ACCOSSORIES (February 10, 1993)
  • K922082 — LAPAROSCOPIC INTRODUCER (August 3, 1992)

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