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510(k) K955236

GREEN TEC-2100 by Medtec, Inc. — Product Code IWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1996
Date Received
November 14, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Patient Position, Light-Beam
Device Class
Class I
Regulation Number
892.5780
Review Panel
RA
Submission Type

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  • K951601 — MED-TEC STRING RETICLE TRAY (May 11, 1995)
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  • K941169 — TEC 2101 (MODEL MT-HPLGD) (July 18, 1994)
  • K935760 — TEC 2100 (MODEL MT-LPLGD) (January 25, 1994)