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510(k) K832601

LEADED X-RAY APRON by E.M. Adams — Product Code EAJ

K832601 is an FDA 510(k) premarket notification submitted by E.M. Adams for the device "LEADED X-RAY APRON". The FDA issued a decision of Substantially Equivalent on September 29, 1983. The device falls under product code EAJ (Apron, Leaded), a Class I device regulated under 21 CFR 892.6500. E.M. Adams has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1983
Date Received
August 2, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apron, Leaded
Device Class
Class I
Regulation Number
892.6500
Review Panel
RA
Submission Type

Other clearances by E.M. Adams

  • K905173 — SPLASH GUARD (April 25, 1991)
  • K910468 — STERILE DISPOSABLE DRAPE(S) (March 21, 1991)
  • K873978 — DISPOSABLE BIPOLAR FORCEPS (November 23, 1987)
  • K850063 — INSTRUMENT POCKET (February 21, 1985)
  • K843724 — I.V. START KIT & OBSTETRICAL KIT (January 10, 1985)
  • K843783 — WET PACK (December 19, 1984)
  • K843782 — DRY TRAY (December 13, 1984)
  • K843723 — STERILE INSTRUMENT TRAYS-VARIOUS (October 23, 1984)
  • K843115 — STERILE SOLUTION BOWL (September 7, 1984)
  • K843116 — DISPOSABLE SKIN MARKING PEN (August 17, 1984)

Other clearances for product code EAJ

  • K931269 — LEAD APRON (June 2, 1993)
  • K913621 — RINN PROTECTIVE X-RAY APRON AND PROTECTIVE COLLAR (September 27, 1991)
  • K870563 — X-RAY APRON (February 19, 1987)
  • K870103 — LEAD APRON CADDY (January 21, 1987)
  • K832602 — THYROID PROTECTIVE COLLAR (September 29, 1983)

FDA data resources