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510(k) K812238

D.I.V.A.S. by Cgr Medical Corp. — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1981
Date Received
August 11, 1981
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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  • K833846 — PROCESS 100 ST (December 16, 1983)
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  • K837465 — ALCYON ROTATIONAL COBALT THERAPY (June 28, 1983)

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