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510(k) K843522

DONWAY SPLINT by Australian Biomedical Corporation , Ltd. — Product Code ITH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1985
Date Received
September 7, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Equipment, Traction, Powered
Device Class
Class II
Regulation Number
890.5900
Review Panel
PM
Submission Type

Other clearances by Australian Biomedical Corporation , Ltd.

  • K871735 — VOROSCOPE(TM) (June 3, 1987)
  • K862457 — LYNX EL MICROSCOPY TISSUE PROCESSOR (July 16, 1986)
  • K851660 — DONWAY LIFTING FRAME (August 7, 1985)
  • K853114 — ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR (August 6, 1985)

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