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510(k) K992655

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

K992655 is an FDA 510(k) premarket notification submitted by Soprane S.A. for the device "FERTILOSCOPY KIT FH 1.29/FTO 1.40". The FDA issued a decision of Substantially Equivalent on March 13, 2000. The device falls under product code HEW (Culdoscope (And Accessories)), a Class II device regulated under 21 CFR 884.1640.

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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FDA data resources