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510(k) K946378

BCM 400CP by B C Medical , Ltd. — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 1995
Date Received
December 23, 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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  • K870205 — ROTAX-II BI-PLANE CIRCULAR ARM (March 6, 1987)
  • K801949 — BCM-302 COLLIMATING CONE & COMPENSATIN (October 3, 1980)
  • K801950 — BCM-600 MINI-SIX EXTRA LG. FIELD ANGIO (October 3, 1980)

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