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510(k) K111340

HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM by Medtec, Inc. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2011
Date Received
May 12, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nuclear Magnetic Resonance Imaging
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

Other clearances by Medtec, Inc.

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  • K974703 — CARBON FIBER BREAST BOARD (March 10, 1998)
  • K974700 — MATRIX MT-MX3 (March 4, 1998)
  • K973842 — CARBON FIBER CONFORMAL COUCH TOP (December 5, 1997)
  • 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)
  • K954225 — MED-TEC HAND GRIP (November 14, 1995)

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