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510(k) K955510

X6000D SILENT SUN LIGHT SOURCE by Products For Medicine — Product Code FST

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1996
Date Received
December 4, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Products For Medicine

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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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