STERILIZATION TRAY, TMJ INSTRUMENT SET

Tray, Surgical, Instrument

ARTHROPEDICS, INC.

The following data is part of a premarket notification filed by Arthropedics, Inc. with the FDA for Sterilization Tray, Tmj Instrument Set.

Pre-market Notification Details

Device IDK871924
510k NumberK871924
Device Name:STERILIZATION TRAY, TMJ INSTRUMENT SET
ClassificationTray, Surgical, Instrument
Applicant ARTHROPEDICS, INC. 111 LESTER ST. Wallington,  NJ  07057
ContactHerbert Schainholz
CorrespondentHerbert Schainholz
ARTHROPEDICS, INC. 111 LESTER ST. Wallington,  NJ  07057
Product CodeFSM  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-05-18
Decision Date1987-06-01

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