KSEA DE LA PLAZA BLEPHAROPLASTY SET

Retractor, Ophthalmic

KARL STORZ ENDOSCOPY-AMERICA, INC.

The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Ksea De La Plaza Blepharoplasty Set.

Pre-market Notification Details

Device IDK991592
510k NumberK991592
Device Name:KSEA DE LA PLAZA BLEPHAROPLASTY SET
ClassificationRetractor, Ophthalmic
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactKevin Kennan
CorrespondentKevin Kennan
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeHNI  
CFR Regulation Number886.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-05-07
Decision Date1999-11-02
Summary:summary

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