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510(k) K924654

FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT by Sutter Corp. — Product Code BXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1993
Date Received
September 15, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Powered
Device Class
Class I
Regulation Number
890.5380
Review Panel
PM
Submission Type

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  • K902707 — MODEL 9000 AT ANKLE CPM DEVICE (July 25, 1990)
  • K890607 — SUTTER HOSPITAL CPM (February 27, 1989)

Other clearances for product code BXB

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  • K953456 — E-Z FLEX (January 26, 1996)
  • K955105 — BTE CPM-10 (December 29, 1995)
  • K955106 — BTE CPM-20 (December 29, 1995)
  • K951028 — HAMEX TWO (December 11, 1995)
  • K950755 — FLEXMATE K500 (October 5, 1995)
  • K945733 — AQUAHAB, MODEL 120-72-101 (September 15, 1995)
  • K951029 — HAMEX ONE (September 15, 1995)