CPC PROBE

Powered Laser Surgical Instrument

CARL ZEISS, INC.

The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Cpc Probe.

Pre-market Notification Details

Device IDK961380
510k NumberK961380
Device Name:CPC PROBE
ClassificationPowered Laser Surgical Instrument
Applicant CARL ZEISS, INC. ONE ZEISS DR. Thornwood,  NY  10594
ContactKenneth M Nicoll
CorrespondentKenneth M Nicoll
CARL ZEISS, INC. ONE ZEISS DR. Thornwood,  NY  10594
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-04-10
Decision Date1997-03-17
Summary:summary

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