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FDA 510(k) Application Details - K021224
Device Classification Name
Set, Anesthesia, Paracervical
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510(K) Number
K021224
Device Name
Set, Anesthesia, Paracervical
Applicant
WALLACH SURGICAL DEVICES, INC.
235 EDISON RD.
ORANGE, CT 06477 US
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Contact
MICHAEL MALIS
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Regulation Number
884.5100
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Classification Product Code
HEE
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More FDA Info for this Product Code
Date Received
04/17/2002
Decision Date
07/12/2002
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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