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510(k) K951808

MED-TEC REDI-FOAM by Medtec, Inc. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1995
Date Received
April 19, 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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  • K954705 — ACRYSTEEL BLOCKING TRAY (January 5, 1996)
  • K954456 — THERMOPLASTIC SHIELD (December 21, 1995)

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