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510(k) K991122

CRYO-MONO CRYOGRNIC SYSTEM by Influence, Inc. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1999
Date Received
April 2, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryosurgical, Accessories
Device Class
Class II
Regulation Number
878.4350
Review Panel
SU
Submission Type

Other clearances by Influence, Inc.

  • K981677 — REPOSE BONE SCREW SYSTEM (August 27, 1999)
  • K991792 — CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE (August 12, 1999)
  • K992277 — STAPLETAC BONE ANCHOR SYSTEM (July 30, 1999)
  • K990160 — MICROTAC-BONE ANCHOR SYSTEM (February 16, 1999)
  • K990095 — STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEM (February 1, 1999)
  • K983325 — IN-PROBE II URODYNAMIC SYSTEM (November 24, 1998)
  • 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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