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510(k) K813462

MADAYAG TYPE NEEDLE by Ocean Medical Products, Ltd. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1982
Date Received
December 11, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type

Other clearances by Ocean Medical Products, Ltd.

  • K882013 — SOFT TISSUE BIOPSY DEVICE (June 15, 1988)
  • K870896 — NOTCH-NEEDLE, WESCOTT STYLE (March 18, 1987)
  • K843719 — SINGLE WALL INTRODUCER NEEDLE (October 18, 1984)
  • K823693 — MYELOGRAPHY NEEDLE (February 7, 1983)
  • K823692 — SPINAL NEEDLE (January 7, 1983)
  • K813448 — POTTS-COURNAND STYLE NEEDLE (January 7, 1982)
  • K813460 — CHIBA SKINNY NEEDLE (January 7, 1982)
  • K813461 — PERCUTANEOUS ENTRY NEEDLE, SELDINGER (December 29, 1981)

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