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510(k) K944445

ED CORP RADIATION SCREEN by Med Corp. — Product Code EAK

K944445 is an FDA 510(k) premarket notification submitted by Med Corp. for the device "ED CORP RADIATION SCREEN". The FDA issued a decision of Substantially Equivalent on May 11, 1995. The device falls under product code EAK (Screen, Leaded, Operator Radiation Protector), a Class I device regulated under 21 CFR 892.6500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1995
Date Received
September 12, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screen, Leaded, Operator Radiation Protector
Device Class
Class I
Regulation Number
892.6500
Review Panel
RA
Submission Type

Other clearances for product code EAK

  • K952233 — CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628 (June 16, 1995)
  • K944772 — MULTIPLE ED1600 SERIES RADIATION SHIELDS (October 20, 1994)
  • K896949 — MOBILE X-RAY PERSONNEL PROTECTIVE SCREENS (February 16, 1990)
  • K861019 — CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD (April 2, 1986)
  • K850816 — LEAD PLASTIC VIEWING PANELS (April 10, 1985)
  • K850814 — MODULAR X-RAY BARRIERS (April 10, 1985)

FDA data resources