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510(k) K091937

OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM by Obp Corporation — Product Code HIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2009
Date Received
June 30, 2009
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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