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510(k) K962528

OLYMPUS MOBILE CHAIR/COUCH by Keymed (Medical & Industrial Equipment), Ltd. — Product Code FZK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1996
Date Received
June 27, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, Surgical, Non-Electrical
Device Class
Class I
Regulation Number
878.4950
Review Panel
SU
Submission Type

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  • K000948 — OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1 (May 12, 2000)
  • K930852 — OLYMPUS SUCTION PUMP MODEL KV-4 (March 31, 1994)
  • K881478 — MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS (September 14, 1988)

Other clearances for product code FZK

  • K842030 — NEUTRAL POS-CHAIR SURGEON CHAIR (July 23, 1984)