FDA 510(k) Application Details - K841825

Device Classification Name Hysteroscope (And Accessories)

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510(K) Number K841825
Device Name Hysteroscope (And Accessories)
Applicant ZINNANTI SURGICAL INSTRUMENTS, INC.

, US
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Regulation Number 884.1690

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Classification Product Code HIH
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Date Received 05/02/1984
Decision Date 06/15/1984
Decision SE - Substantially Equivalent
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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