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510(k) K952729

PAINTED WEDGE & ROD BREAST BOARD by Medtec, Inc. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1995
Date Received
June 15, 1995
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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  • K962622 — INTRA-ORAL THERMOPLASTIC SHIELD (October 1, 1996)
  • K955236 — GREEN TEC-2100 (May 24, 1996)
  • K954705 — ACRYSTEEL BLOCKING TRAY (January 5, 1996)
  • K954456 — THERMOPLASTIC SHIELD (December 21, 1995)

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