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510(k) K951627

INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEM by Infinitech, Inc. — Product Code MPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1995
Date Received
April 7, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoilluminator
Device Class
Class II
Regulation Number
876.1500
Review Panel
OP
Submission Type

Other clearances by Infinitech, Inc.

  • K972506 — INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR (October 1, 1997)
  • K971950 — INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER (August 1, 1997)
  • K931264 — INFINITECH OTOPROBE (March 1, 1994)
  • K931546 — END-IRRIGATING ENDOILLUMINATOR (February 9, 1994)
  • K935441 — INFINITECH BREATH EZ (February 7, 1994)

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