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510(k) K020447

MITYVAC MERLIN, MODEL 10027 by Prism Enterprises, Inc. — Product Code HDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2002
Date Received
February 11, 2002
Clearance Type
Special
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

Other clearances by Prism Enterprises, Inc.

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