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510(k) K043614

VACULINK, MODEL VCL 3000 by Medevco, Inc. — Product Code HDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2005
Date Received
December 30, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extractor, Vacuum, Fetal
Device Class
Class II
Regulation Number
884.4340
Review Panel
OB
Submission Type

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