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510(k) K871502

PERSONNEL PROTECTIVE SHIELD by Cis-Us, Inc. — Product Code KPY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1987
Date Received
April 17, 1987
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 Cis-Us, Inc.

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  • K882449 — CESIUM 137 SOURCE, MODEL CSM-40 (April 14, 1989)
  • K865027 — IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C (February 26, 1987)
  • K863778 — VENTICIS II (October 27, 1986)
  • K860823 — ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT (August 19, 1986)
  • K860824 — TSHK-NN RIA KIT (April 28, 1986)

Other clearances for product code KPY

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  • 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)