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510(k) K950633

CANDELA URETHRAL/BLADDER SOUND by Candela Laser Corp. — Product Code FBX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1995
Date Received
February 13, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sound, Urethral, Metal Or Plastic
Device Class
Class I
Regulation Number
876.5520
Review Panel
GU
Submission Type

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