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510(k) K023019

VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000 by Vomed Volzer Medizintechnik GmbH & Co. — Product Code FGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2002
Date Received
September 11, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urethrographic, Male
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Vomed Volzer Medizintechnik GmbH & Co.

  • K022257 — VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 (October 4, 2002)
  • K022318 — VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES (September 19, 2002)

Other clearances for product code FGI

  • K013360 — DFINER UROLOGICAL CATHETER (February 20, 2002)
  • K810370 — POLLACK CHAIN CYSOURETHROGRAM SET (March 20, 1981)