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510(k) K983325

IN-PROBE II URODYNAMIC SYSTEM by Influence, Inc. — Product Code FEN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1998
Date Received
September 22, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Cystometric, Hydraulic
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type

Other clearances by Influence, Inc.

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  • K991122 — CRYO-MONO CRYOGRNIC SYSTEM (July 1, 1999)
  • K990160 — MICROTAC-BONE ANCHOR SYSTEM (February 16, 1999)
  • K990095 — STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEM (February 1, 1999)
  • K982155 — SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM (August 31, 1998)
  • K981631 — INFLUENCE CLIP SYSTEM (July 28, 1998)
  • K980482 — TRIANGLE SLING (March 27, 1998)
  • K972622 — STRAIGHT-IN BONE SCREW FIXATION SYSTEM (October 9, 1997)

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  • K992715 — NEURO URODYNAMIC SUITE, MODEL 9032E0101 (February 28, 2000)
  • K970595 — CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP (October 24, 1997)
  • K971911 — LUMAX CYSTOMETRY ADMINISTRATION TUBE SET (June 3, 1997)
  • K964522 — ELLIPSE 4 (March 21, 1997)
  • K960503 — DANTEC DUET (September 16, 1996)
  • K953734 — LUMAX(MODIFICATION) (January 18, 1996)