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510(k) K934459

MED-GENESIS PATIENT LASER EYE SHIELD by Med-Genesis, Inc. — Product Code IWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1994
Date Received
September 10, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shield, Eye, Radiological
Device Class
Class I
Regulation Number
892.6500
Review Panel
RA
Submission Type

Other clearances for product code IWS

  • K945515 — COATED TUNGSTEN EYESHIELD (June 19, 1995)
  • K940119 — ROYAL MARSDEN GOLD GRAIN GUN (December 30, 1994)
  • K943011 — TUNGSTEN EYESHIELD (December 23, 1994)
  • K934362 — NUCLEAR ASSOCIATES GLASSERS (November 12, 1993)
  • K920540 — RADIOLOGICAL PROTECTIVE EYE SHIELD (May 28, 1992)