STORZ D4600 AIR EXCHANGE LINE PACK

Unit, Phacofragmentation

STORZ INSTRUMENT CO.

The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz D4600 Air Exchange Line Pack.

Pre-market Notification Details

Device IDK962131
510k NumberK962131
Device Name:STORZ D4600 AIR EXCHANGE LINE PACK
ClassificationUnit, Phacofragmentation
Applicant STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis,  MO  63122 -6694
ContactAudrey Swearingen
CorrespondentAudrey Swearingen
STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis,  MO  63122 -6694
Product CodeHQC  
CFR Regulation Number886.4670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-03
Decision Date1996-08-23
Summary:summary

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