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510(k) K934362

NUCLEAR ASSOCIATES GLASSERS by Victoreen, Inc. — Product Code IWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1993
Date Received
September 8, 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

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Other clearances for product code IWS

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  • K934459 — MED-GENESIS PATIENT LASER EYE SHIELD (February 22, 1994)
  • K920540 — RADIOLOGICAL PROTECTIVE EYE SHIELD (May 28, 1992)