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510(k) K080621

FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01 by European Custom Manufacturing BV — Product Code DSA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2008
Date Received
March 5, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Device Class
Class II
Regulation Number
870.2900
Review Panel
CV
Submission Type

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