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510(k) K882657

HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT by Harbor Medical Devices, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1988
Date Received
June 29, 1988
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 Harbor Medical Devices, Inc.

  • K884628 — HARBORIN CENTRAL VENOUS CATHETER (May 15, 1989)
  • K890518 — SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM (April 21, 1989)
  • K881884 — HARBOR CENTRAL VENOUS CATHETER (July 28, 1988)
  • K882190 — S.E.A.-PORT(TM) VASCULAR ACCESS SYSTEM (June 9, 1988)
  • K880297 — SEA - PORT INFUSION SET (February 19, 1988)
  • K874414 — HYPODERMIC NEEDLES, SINGLE LUMEN (January 14, 1988)

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