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510(k) K900970

RADIATION PROTECTION GLASSES by Infab Corp. — Product Code KPY

K900970 is an FDA 510(k) premarket notification submitted by Infab Corp. for the device "RADIATION PROTECTION GLASSES". The FDA issued a decision of Substantially Equivalent on May 1, 1990. The device falls under product code KPY (Shield, Protective, Personnel), a Class I device regulated under 21 CFR 892.6500. Infab Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1990
Date Received
March 2, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shield, Protective, Personnel
Device Class
Class I
Regulation Number
892.6500
Review Panel
RA
Submission Type

Other clearances by Infab Corp.

  • K900972 — RADIATION PROTECTION GLOVES (May 1, 1990)
  • K901014 — RADIOGRAPHIC INTENSIFYING SCREEN (April 2, 1990)
  • K901012 — RADIOGRAPHIC GRID (March 28, 1990)
  • K901013 — RADIOGRAPHIC FILM CASSETTE (March 28, 1990)
  • K896289 — RADIATION PROTECTION APRON (December 14, 1989)

Other clearances for product code KPY

  • K110900 — DISPOSABLE THYROID COLLAR (June 24, 2011)
  • K962622 — INTRA-ORAL THERMOPLASTIC SHIELD (October 1, 1996)
  • K954456 — THERMOPLASTIC SHIELD (December 21, 1995)
  • K954146 — UTK-DTE AUTILARY SHIELD (December 6, 1995)
  • K953610 — AUKULYTE (September 26, 1995)
  • K951004 — 2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4) (April 10, 1995)
  • K951003 — KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) (April 3, 1995)
  • K940539 — STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM (March 16, 1994)
  • K934206 — MAVIG ANGIO SHIELD MODELS 6290 & 6272 (October 7, 1993)
  • K912326 — DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS (March 18, 1992)

FDA data resources