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510(k) K921221

Device
STERILE/SINGLE USE SYMBLEPHARON RING
Applicant
STORZ INSTRUMENT CO.
510(k) number
K921221
Product code
HQN  
Decision
Substantially Equivalent (SESE)
Decision date
1992-07-17
Date received
1992-03-13
Regulation
886.3130
Classification name
Conformer, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JANET LACAVICH
Address
3365 Tree Ct. Industrial Blvd. St. Louis MO US 63122 63122

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HQN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K972034MEDPOR OCULAR CONFORMERPorex Surgical, Inc.1998-01-20
K970318OCULAR CONFORMERSouthwest Artificial Eyes, Inc.1997-07-07
K970319OCULAR CONFORMERXavier A. Guerra, Ocularist, Inc.1997-07-07
K945110KOLBERG OPHTHALMIC CONFORMERKolberg Ocular Products, Inc.1995-01-13
K921229STERILE/SINGLE USE OPHTHALMIC CONFORMERSStorz Instrument Co.1992-06-09
K772168MOLDEYERobert B. Scott Ocularists of Florida, Inc.1977-11-30

Legacy Summary#

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FDA Review#

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