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510(k) K943011

TUNGSTEN EYESHIELD by Medtec, Inc. — Product Code IWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1994
Date Received
June 24, 1994
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

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Other clearances for product code IWS

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  • K934459 — MED-GENESIS PATIENT LASER EYE SHIELD (February 22, 1994)
  • K934362 — NUCLEAR ASSOCIATES GLASSERS (November 12, 1993)
  • K920540 — RADIOLOGICAL PROTECTIVE EYE SHIELD (May 28, 1992)