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510(k) K811833

VNACE FASCIAL DILATOR SET by Vance Products, Inc. — Product Code KOE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1981
Date Received
June 30, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Urethral
Device Class
Class II
Regulation Number
876.5520
Review Panel
GU
Submission Type

Other clearances by Vance Products, Inc.

  • K820313 — VPI-FAIR URETHRAL STENT (March 1, 1982)
  • K812995 — VANCE-JACOBELLIS MICROHEMATURIA CATHETER (March 1, 1982)
  • K813278 — VPI URETERAL DILATATION BALLON CATHETER (December 18, 1981)
  • K812785 — VANCE-AMBROSE RESECTOSCOPE FORCEPS (November 16, 1981)
  • K812057 — VANCE CYSTOSCOPIC (July 31, 1981)
  • K811454 — VANCE PROSTATIC ASPIRATION SET (June 9, 1981)
  • K810372 — VANCE DEFLECTABLE BIOPSY BRUSH SET (March 20, 1981)
  • K810367 — KISH URETHRAL ILLUMINATED CATHETER SET (March 20, 1981)
  • K810368 — VANCE PERCUTANEOUS MALECOT NEPHROSTOMY (March 20, 1981)
  • K810370 — POLLACK CHAIN CYSOURETHROGRAM SET (March 20, 1981)

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  • K920711 — ENTRAC URETHRAL BALLOON DILATATION CATHETER (May 6, 1992)
  • K913477 — APEX(TM) PROSTATIC BALLOON DILATION CATHETER (December 27, 1991)