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510(k) K813461

PERCUTANEOUS ENTRY NEEDLE, SELDINGER by Ocean Medical Products, Ltd. — Product Code DRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1981
Date Received
December 11, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, For Percutaneous Catheterization
Device Class
Class II
Regulation Number
870.1310
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)
  • K843719 — SINGLE WALL INTRODUCER NEEDLE (October 18, 1984)
  • 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)

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