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510(k) K973853

KOLPLAST VAGINAL SPECULUM by Kolplast Comercial E Industrial Ltda — Product Code HIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1997
Date Received
October 8, 1997
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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