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510(k) K072762

DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM by Depalt, Inc. — Product Code HIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2008
Date Received
September 28, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Speculum, Vaginal, Nonmetal
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

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