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510(k) K974703

CARBON FIBER BREAST BOARD by Medtec, Inc. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1998
Date Received
December 16, 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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  • K973842 — CARBON FIBER CONFORMAL COUCH TOP (December 5, 1997)
  • K962622 — INTRA-ORAL THERMOPLASTIC SHIELD (October 1, 1996)
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  • K954705 — ACRYSTEEL BLOCKING TRAY (January 5, 1996)
  • K954456 — THERMOPLASTIC SHIELD (December 21, 1995)
  • K954225 — MED-TEC HAND GRIP (November 14, 1995)

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