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510(k) K896289

RADIATION PROTECTION APRON by Infab Corp. — Product Code KPY

K896289 is an FDA 510(k) premarket notification submitted by Infab Corp. for the device "RADIATION PROTECTION APRON". The FDA issued a decision of Substantially Equivalent on December 14, 1989. 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
December 14, 1989
Date Received
October 31, 1989
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)
  • K900970 — RADIATION PROTECTION GLASSES (May 1, 1990)
  • K901014 — RADIOGRAPHIC INTENSIFYING SCREEN (April 2, 1990)
  • K901012 — RADIOGRAPHIC GRID (March 28, 1990)
  • K901013 — RADIOGRAPHIC FILM CASSETTE (March 28, 1990)

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)
  • K912378 — DAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. NUMBERS (March 18, 1992)

FDA data resources