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510(k) K870896

NOTCH-NEEDLE, WESCOTT STYLE by Ocean Medical Products, Ltd. — Product Code GAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1987
Date Received
March 5, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Aspiration And Injection, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Ocean Medical Products, Ltd.

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  • 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)
  • K813461 — PERCUTANEOUS ENTRY NEEDLE, SELDINGER (December 29, 1981)

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