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510(k) K032847

EXCISOR BIOPTOME, MODEL 01-0004 by Acueity, Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2003
Date Received
September 12, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Acueity, Inc.

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  • K011189 — VIADUCT MICROENDOSCOPE AND ACCESSORIES (July 16, 2001)

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