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510(k) K032156

ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT by Wfr/Aquaplast Corp. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2003
Date Received
July 14, 2003
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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  • K021124 — ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER (July 2, 2002)
  • K973370 — AQUAPLAST PALATAL STENT (December 2, 1997)
  • K943871 — AQUAPLAST TIE DOWN DRESSING (September 30, 1994)
  • K942158 — AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS (July 29, 1994)
  • K935067 — AQUAPLAST (May 26, 1994)

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