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510(k) K870983

NOCTURNAL PENILE TUMESCENCE MONITOR by Texas Medical Electronics Co. — Product Code LIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1987
Date Received
March 10, 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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