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510(k) K971382

PRONE BREAST POSITIONING BOARD, MODEL #37-018 by Victoreen, Inc. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1997
Date Received
March 14, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

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  • K941931 — DIAGNOSTIC X-RAY PATIENT EXPOSURE INDICATOR (May 26, 1994)
  • K934549 — ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD (February 19, 1994)

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