CASSETTE SYSTEM FOR SITE

Unit, Phacofragmentation

SURGIN SURGICAL INSTRUMENTATION, INC.

The following data is part of a premarket notification filed by Surgin Surgical Instrumentation, Inc. with the FDA for Cassette System For Site.

Pre-market Notification Details

Device IDK942518
510k NumberK942518
Device Name:CASSETTE SYSTEM FOR SITE
ClassificationUnit, Phacofragmentation
Applicant SURGIN SURGICAL INSTRUMENTATION, INC. 14762 BENTLEY CIRCLE Tustin,  CA  92680
ContactDon Haar
CorrespondentDon Haar
SURGIN SURGICAL INSTRUMENTATION, INC. 14762 BENTLEY CIRCLE Tustin,  CA  92680
Product CodeHQC  
CFR Regulation Number886.4670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-05-26
Decision Date1994-07-25

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