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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Conformer, Ophthalmic
510(k) Number K921229
Device Name STERILE/SINGLE USE OPHTHALMIC CONFORMERS
Applicant
Storz Instrument Co.
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Applicant Contact JANET LACAVICH
Correspondent
Storz Instrument Co.
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Correspondent Contact JANET LACAVICH
Regulation Number886.3130
Classification Product Code
HQN  
Date Received03/13/1992
Decision Date 06/09/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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