VITRECTOMY PACK #J120

Unit, Phacofragmentation

O.R. SPECIALTIES, INC.

The following data is part of a premarket notification filed by O.r. Specialties, Inc. with the FDA for Vitrectomy Pack #j120.

Pre-market Notification Details

Device IDK891161
510k NumberK891161
Device Name:VITRECTOMY PACK #J120
ClassificationUnit, Phacofragmentation
Applicant O.R. SPECIALTIES, INC. 4749 APPLETREE LN. Tuscaloosa,  AL  35405
ContactJack W Howard
CorrespondentJack W Howard
O.R. SPECIALTIES, INC. 4749 APPLETREE LN. Tuscaloosa,  AL  35405
Product CodeHQC  
CFR Regulation Number886.4670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-03-06
Decision Date1989-05-26

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