FDA 510(k) Application Details - K020959

Device Classification Name Speculum, Vaginal, Nonmetal

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510(K) Number K020959
Device Name Speculum, Vaginal, Nonmetal
Applicant SOL WEISS MD INC
7012 RESEDA BLVD.
SUITE A
RESEDA, CA 91335 US
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Contact SOL WEISS
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Regulation Number 884.4530

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Classification Product Code HIB
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Date Received 03/25/2002
Decision Date 06/19/2002
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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