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510(k) K073182

GYN DISPOSABLES TENACULUM 356T by Gyn-Disposables, Inc. — Product Code HDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2007
Date Received
November 13, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Tenaculum, Uterine
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

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