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510(k) K991592

Device
KSEA DE LA PLAZA BLEPHAROPLASTY SET
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
510(k) number
K991592
Product code
HNI  
Decision
Substantially Equivalent (SESE)
Decision date
1999-11-02
Date received
1999-05-07
Regulation
886.4350
Classification name
Retractor, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KEVIN KENNAN
Address
600 Corporate Pt.e Culver City CA US 90230 90230

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HNI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K770222IRIS RETRACTORConcept, Inc.1977-02-17

Legacy Summary#

summary

FDA Review#

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