VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND

Colposcope (and Colpomicroscope)

WELCH ALLYN, INC.

The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Video Colposcope/vertical Rolling Base/swing Arm Stand.

Pre-market Notification Details

Device IDK955635
510k NumberK955635
Device Name:VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND
ClassificationColposcope (and Colpomicroscope)
Applicant WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls,  NY  13153 -0220
ContactLawrence E Marocco
CorrespondentLawrence E Marocco
WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls,  NY  13153 -0220
Product CodeHEX  
CFR Regulation Number884.1630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-11
Decision Date1996-05-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00732094136098 K955635 000
00732094053456 K955635 000

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