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510(k) K831384

COAXIAL BALLOON URETHRAL DILATOR by Thomas J. Fogarty, M.D. — Product Code FAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1983
Date Received
April 28, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Urethral, Mechanical
Device Class
Class II
Regulation Number
876.5520
Review Panel
GU
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)
  • K831809 — FOGARTY OCCLUDER PAD (August 27, 1984)
  • K841310 — GASTROINTESTINAL DILATOR (July 31, 1984)
  • K834451 — COAXIAL BALLOON GASTROESOPHAGEAL DILA (February 4, 1984)

Other clearances for product code FAH

  • K933957 — DILATING URETHRAL SOUND (November 17, 1993)
  • K902370 — MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER (August 17, 1990)
  • K902124 — DOWD CATHETER (August 9, 1990)