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510(k) K992655

FERTILOSCOPY KIT FH 1.29/FTO 1.40 by Soprane S.A. — Product Code HEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2000
Date Received
August 9, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culdoscope (And Accessories)
Device Class
Class II
Regulation Number
884.1640
Review Panel
OB
Submission Type

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