FDA 510(k) Application Details - K980972

Device Classification Name Culdoscope (And Accessories)

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510(K) Number K980972
Device Name Culdoscope (And Accessories)
Applicant CIRCON CORP.
6500 HOLLISTER AVE.
SANTA BARBARA, CA 93117-3019 US
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Contact RONALD J EHMSEN
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Regulation Number 884.1640

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Classification Product Code HEW
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Date Received 03/16/1998
Decision Date 06/12/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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