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510(k) K954414

CENTRALITE BACKPOINTER by Diacor, Inc. — Product Code IWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1995
Date Received
September 21, 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

Other clearances by Diacor, Inc.

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  • K953046 — PERI-PUSHER (September 22, 1995)
  • K950112 — CENTRALITE(R)-DLL SERIES (August 16, 1995)
  • K934566 — RADASSIST (November 3, 1993)
  • K930246 — MAMMORX (July 26, 1993)
  • K893398 — CENTRALITE BACKPOINTER (August 17, 1989)
  • K872489 — CENTRALITE (July 15, 1987)
  • K860193 — PORTALCAST (January 30, 1986)

Other clearances for product code IWE

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  • K973162 — DUAL RADIATION TARGETING SYSTEM DRTS DRAPE (November 20, 1997)
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  • K950293 — TEC-2110 GREEN LASER MODEL MT-HNG (August 18, 1995)
  • K950112 — CENTRALITE(R)-DLL SERIES (August 16, 1995)
  • K951601 — MED-TEC STRING RETICLE TRAY (May 11, 1995)
  • K943802 — HP BACK POINTER SYSTEM (December 7, 1994)
  • K943381 — LASER ALIGNMENT TOOL (August 9, 1994)
  • K941169 — TEC 2101 (MODEL MT-HPLGD) (July 18, 1994)
  • K935760 — TEC 2100 (MODEL MT-LPLGD) (January 25, 1994)