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510(k) K954456

THERMOPLASTIC SHIELD by Medtec, Inc. — Product Code KPY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1995
Date Received
September 25, 1995
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

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  • K093738 — MRI PATIENT POSITIONING DEVICES (May 14, 2010)
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  • 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)
  • K954225 — MED-TEC HAND GRIP (November 14, 1995)

Other clearances for product code KPY

  • K110900 — DISPOSABLE THYROID COLLAR (June 24, 2011)
  • K962622 — INTRA-ORAL THERMOPLASTIC SHIELD (October 1, 1996)
  • 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)
  • K912327 — DAVIS LEAD APRON GONADAL SHIELD-VARIOUS CAT. NOS. (March 18, 1992)