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510(k) K041579

MEDELA SINGLE USE SILC CUP, MODEL 077.0791 by Medela AG — Product Code HDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2005
Date Received
June 14, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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