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510(k) K120127

SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM by Swan Valley Medical, Incorporated — Product Code KOB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2012
Date Received
January 17, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Suprapubic (And Accessories)
Device Class
Class II
Regulation Number
876.5090
Review Panel
GU
Submission Type

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