STERILE/SINGLE USE OPHTHALMIC CONFORMERS

Conformer, Ophthalmic

STORZ INSTRUMENT CO.

The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Sterile/single Use Ophthalmic Conformers.

Pre-market Notification Details

Device IDK921229
510k NumberK921229
Device Name:STERILE/SINGLE USE OPHTHALMIC CONFORMERS
ClassificationConformer, Ophthalmic
Applicant STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis,  MO  63122 -6694
ContactJanet Lacavich
CorrespondentJanet Lacavich
STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis,  MO  63122 -6694
Product CodeHQN  
CFR Regulation Number886.3130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-13
Decision Date1992-06-09

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