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510(k) K971790

KNOLL/MIDUS (MALE IMPOTENCE DIAGNOSTIC ULTRASONIC SYSTEM) by Urometrics, Inc. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1997
Date Received
May 14, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

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