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510(k) K933957

DILATING URETHRAL SOUND by Cook Urological, Inc. — Product Code FAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1993
Date Received
August 12, 1993
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

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Other clearances for product code FAH

  • K902370 — MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER (August 17, 1990)
  • K902124 — DOWD CATHETER (August 9, 1990)
  • K831384 — COAXIAL BALLOON URETHRAL DILATOR (July 26, 1983)