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510(k) K061646

LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES by Laserscope — Product Code FBO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2006
Date Received
June 12, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Cystourethroscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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  • K972979 — SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RI (December 11, 1997)
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