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510(k) K900494

SYNECTICS LIBERTY SYSTEM, PC POLYGRAF & POLYGRAM by Synectics-Dantec — Product Code FAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1990
Date Received
February 2, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type

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  • K931175 — SCHUSTER DISPOSABLE BALLOON PROBE (April 1, 1994)
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  • K922476 — URO-PRO 2000 (July 20, 1993)
  • K924383 — SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO (June 18, 1993)
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