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510(k) K945540

CAAS II by Pie Medical Equipment B.V. — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1995
Date Received
November 14, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

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  • K911044 — 7.5 MHZ APAS TRANSDUCER (ART.NOL: 50.04918.1) (October 7, 1991)
  • K900838 — TRANSVAGINAL TRANSDUCER ASSEMBLY (May 23, 1990)

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