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FDA 510(k) Application Details - K012535
Device Classification Name
Speculum, Vaginal, Nonmetal
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510(K) Number
K012535
Device Name
Speculum, Vaginal, Nonmetal
Applicant
DOCTOR'S RESEARCH GROUP, INC.
143 WOLCOTT RD.
WOLCOTT, CT 06716 US
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Contact
RICHARD DESLAURIERS
Other 510(k) Applications for this Contact
Regulation Number
884.4530
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Classification Product Code
HIB
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More FDA Info for this Product Code
Date Received
08/07/2001
Decision Date
03/01/2002
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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