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510(k) K002546

CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE by CIVCO Medical Instruments Co., Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2000
Date Received
August 17, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type

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  • K080072 — MRI PATIENT POSITIONING DEVICES (June 4, 2008)
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  • K992152 — GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCA (August 17, 1999)

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