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510(k) K831809

FOGARTY OCCLUDER PAD by Thomas J. Fogarty, M.D. — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1984
Date Received
June 6, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type

Other clearances by Thomas J. Fogarty, M.D.

  • K902453 — OSCILLOMETRIC PULSE DETECTION DEVICE (August 23, 1990)
  • K884154 — TRANSLUMINAL ENDARTERECTOMY DEVICE (December 27, 1988)
  • K841310 — GASTROINTESTINAL DILATOR (July 31, 1984)
  • K834451 — COAXIAL BALLOON GASTROESOPHAGEAL DILA (February 4, 1984)
  • K831384 — COAXIAL BALLOON URETHRAL DILATOR (July 26, 1983)

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