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510(k) K900760

AMS OPTILUME INFLATION SYRINGE by American Medical Systems, Inc. — Product Code KOE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1990
Date Received
February 16, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Urethral
Device Class
Class II
Regulation Number
876.5520
Review Panel
GU
Submission Type

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  • K920711 — ENTRAC URETHRAL BALLOON DILATATION CATHETER (May 6, 1992)
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