PROCEDURE KIT/ROUTINE DENTAL PROCEDURES

File, Pulp Canal, Endodontic

ANGIOSYSTEMS, INC.

The following data is part of a premarket notification filed by Angiosystems, Inc. with the FDA for Procedure Kit/routine Dental Procedures.

Pre-market Notification Details

Device IDK905461
510k NumberK905461
Device Name:PROCEDURE KIT/ROUTINE DENTAL PROCEDURES
ClassificationFile, Pulp Canal, Endodontic
Applicant ANGIOSYSTEMS, INC. C/O MEDICAL DEVICE INSPECITON 55 NORTHERN BLVD., SUITE 301 Great Neck,  NY  11021
ContactAlan P Schwartz
CorrespondentAlan P Schwartz
ANGIOSYSTEMS, INC. C/O MEDICAL DEVICE INSPECITON 55 NORTHERN BLVD., SUITE 301 Great Neck,  NY  11021
Product CodeEKS  
CFR Regulation Number872.4565 [🔎]
DecisionSubstantially Equivalent - Kit With Drugs (SEKD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-05
Decision Date1991-03-05

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