MODEL C2100-SERIES OPHTHALMIC CRYOPROBE

Unit, Cryosurgical, Accessories

VALLEYLAB, INC.

The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Model C2100-series Ophthalmic Cryoprobe.

Pre-market Notification Details

Device IDK810409
510k NumberK810409
Device Name:MODEL C2100-SERIES OPHTHALMIC CRYOPROBE
ClassificationUnit, Cryosurgical, Accessories
Applicant VALLEYLAB, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGEH  
CFR Regulation Number878.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-02-18
Decision Date1981-03-20

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