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510(k) K934362

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

K934362 is an FDA 510(k) premarket notification submitted by Victoreen, Inc. for the device "NUCLEAR ASSOCIATES GLASSERS". The FDA issued a decision of Substantially Equivalent on November 12, 1993. The device falls under product code IWS (Shield, Eye, Radiological), a Class I device regulated under 21 CFR 892.6500. Victoreen, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Victoreen, Inc.

  • K982937 — MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER (November 19, 1998)
  • K974112 — VACUDAP, MODEL 2000, 2001 (January 29, 1998)
  • K973960 — MODEL 37-185 (January 14, 1998)
  • K964952 — VERIDOSE V (FIVE), MODEL NUMBER 37-705 (July 21, 1997)
  • K964785 — VERIDOSE DIODES (June 13, 1997)
  • K971382 — PRONE BREAST POSITIONING BOARD, MODEL #37-018 (June 6, 1997)
  • K952233 — CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628 (June 16, 1995)
  • K940660 — MODEL 37-720 DUAL DIODE DOSIMETRY SYSTEM (December 9, 1994)
  • K935435 — NUCLEAR ASSOC 37-08 SER, RAYCAST HP RADIO IMMOB SYST (July 29, 1994)
  • K941931 — DIAGNOSTIC X-RAY PATIENT EXPOSURE INDICATOR (May 26, 1994)

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

FDA data resources