SOLOS EYESITE DRAPES

Drape, Patient, Ophthalmic

SOLOS OPHTHALMOLOGY

The following data is part of a premarket notification filed by Solos Ophthalmology with the FDA for Solos Eyesite Drapes.

Pre-market Notification Details

Device IDK872620
510k NumberK872620
Device Name:SOLOS EYESITE DRAPES
ClassificationDrape, Patient, Ophthalmic
Applicant SOLOS OPHTHALMOLOGY 6191 ATLANTIC BLVD. Norcross,  GA  30071
ContactStephen Holmes
CorrespondentStephen Holmes
SOLOS OPHTHALMOLOGY 6191 ATLANTIC BLVD. Norcross,  GA  30071
Product CodeHMT  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-06
Decision Date1987-07-31

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