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510(k) K945515

COATED TUNGSTEN EYESHIELD by Medtec, Inc. — Product Code IWS

K945515 is an FDA 510(k) premarket notification submitted by Medtec, Inc. for the device "COATED TUNGSTEN EYESHIELD". The FDA issued a decision of Substantially Equivalent on June 19, 1995. The device falls under product code IWS (Shield, Eye, Radiological), a Class I device regulated under 21 CFR 892.6500. Medtec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1995
Date Received
November 9, 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

Other clearances by Medtec, Inc.

  • K132908 — TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT A (March 4, 2014)
  • K111340 — HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM (June 28, 2011)
  • K093738 — MRI PATIENT POSITIONING DEVICES (May 14, 2010)
  • K974703 — CARBON FIBER BREAST BOARD (March 10, 1998)
  • K974700 — MATRIX MT-MX3 (March 4, 1998)
  • K973842 — CARBON FIBER CONFORMAL COUCH TOP (December 5, 1997)
  • K962622 — INTRA-ORAL THERMOPLASTIC SHIELD (October 1, 1996)
  • K955236 — GREEN TEC-2100 (May 24, 1996)
  • K954705 — ACRYSTEEL BLOCKING TRAY (January 5, 1996)
  • K954456 — THERMOPLASTIC SHIELD (December 21, 1995)

Other clearances for product code IWS

  • 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)
  • K934362 — NUCLEAR ASSOCIATES GLASSERS (November 12, 1993)
  • K920540 — RADIOLOGICAL PROTECTIVE EYE SHIELD (May 28, 1992)

FDA data resources