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510(k) K061676

RIGIDOMETER, MODEL DIR-4U by Uroan 21 — Product Code LIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2006
Date Received
June 14, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Penile Tumescence
Device Class
Class U
Regulation Number
Review Panel
GU
Submission Type

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  • K980627 — NEVA SYSTEM (April 7, 1998)
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  • K941781 — RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM (August 25, 1994)
  • K925931 — RT2 RIGIDITY AND TUMESCENCE TEST (December 21, 1992)