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510(k) K875333

SURGITEK NPT MONITOR by Surgitek — Product Code LIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1988
Date Received
December 30, 1987
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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  • K940128 — CAT-400UL PENILE PLETHYSMOGRAPH (January 10, 1995)
  • K936115 — CAT-600 PENILE PLETHYSMOGRAPH (January 10, 1995)
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