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510(k) K022384

XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP by Isolux America — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2002
Date Received
July 22, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type

Other clearances by Isolux America

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  • K991208 — ENDOSCOPIC FIBEROPTIC CABLE (June 23, 1999)

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