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510(k) K031213

AQUASENS FLUID MONITORING SYSTEM by Davol, Inc. — Product Code HIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2003
Date Received
April 17, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Insufflator, Hysteroscopic
Device Class
Class II
Regulation Number
884.1700
Review Panel
OB
Submission Type

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