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510(k) K961248

BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS by C.R. Bard, Inc. — Product Code FFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1996
Date Received
April 1, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dislodger, Stone, Basket, Ureteral, Metal
Device Class
Class II
Regulation Number
876.4680
Review Panel
GU
Submission Type

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Other clearances for product code FFL

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  • K082803 — COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 (November 13, 2008)
  • K052048 — ACCORDION (September 13, 2005)
  • K012581 — REPROCESSED STONE RETRIEVAL BASKETS (February 14, 2002)
  • K972091 — AMS FOREIGN BODY EXTRATOR (August 29, 1997)
  • K970489 — COMEG ENDOSCOPY GRASPING FORCEPS (March 19, 1997)
  • K962387 — OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY) (July 31, 1996)
  • K955049 — OLYMPUS FG-45/46-1 GRASPING FORCEPS (December 15, 1995)