STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY

Drape, Patient, Ophthalmic

ANGIOSYSTEMS, INC.

The following data is part of a premarket notification filed by Angiosystems, Inc. with the FDA for Sterile Disposable Drape/ophthalmic Surgery.

Pre-market Notification Details

Device IDK905460
510k NumberK905460
Device Name:STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY
ClassificationDrape, Patient, Ophthalmic
Applicant ANGIOSYSTEMS, INC. C/O MEDICAL DEVICE INSPECITON 55 NORTHERN BLVD., SUITE 301 Great Neck,  NY  11021
ContactAlan P Scwartz
CorrespondentAlan P Scwartz
ANGIOSYSTEMS, INC. C/O MEDICAL DEVICE INSPECITON 55 NORTHERN BLVD., SUITE 301 Great Neck,  NY  11021
Product CodeHMT  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-05
Decision Date1991-02-06

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