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510(k) K963227

WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175 by Products For Medicine — Product Code GCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1996
Date Received
August 19, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Source, Endoscope, Xenon Arc
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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  • K951704 — NON-WOVEN FILTER PAPER FOR STEAM AND GAS STERILIZATION (June 28, 1995)
  • K883658 — I-SPOSE EYE SHIELD (October 25, 1988)

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