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510(k) K843719

SINGLE WALL INTRODUCER NEEDLE by Ocean Medical Products, Ltd. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1984
Date Received
September 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
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)
  • K823693 — MYELOGRAPHY NEEDLE (February 7, 1983)
  • K823692 — SPINAL NEEDLE (January 7, 1983)
  • K813462 — MADAYAG TYPE NEEDLE (March 1, 1982)
  • K813460 — CHIBA SKINNY NEEDLE (January 7, 1982)
  • K813448 — POTTS-COURNAND STYLE NEEDLE (January 7, 1982)
  • K813461 — PERCUTANEOUS ENTRY NEEDLE, SELDINGER (December 29, 1981)

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