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510(k) K032644

KOLPEXIN SPHERE by Adamed , Ltd. — Product Code HHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2004
Date Received
August 27, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pessary, Vaginal
Device Class
Class II
Regulation Number
884.3575
Review Panel
OB
Submission Type

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