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FDA 510(k) Application Details - K955635
Device Classification Name
Colposcope (And Colpomicroscope)
More FDA Info for this Device
510(K) Number
K955635
Device Name
Colposcope (And Colpomicroscope)
Applicant
WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
SKANEATELES FALLS, NY 13153-0220 US
Other 510(k) Applications for this Company
Contact
LAWRENCE E MAROCCO
Other 510(k) Applications for this Contact
Regulation Number
884.1630
More FDA Info for this Regulation Number
Classification Product Code
HEX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/11/1995
Decision Date
05/07/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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