TRIANGULAR KNIFE, DISPOSABLE #TM-1611

Knife, Orthopedic

ARTHROPEDICS, INC.

The following data is part of a premarket notification filed by Arthropedics, Inc. with the FDA for Triangular Knife, Disposable #tm-1611.

Pre-market Notification Details

Device IDK873713
510k NumberK873713
Device Name:TRIANGULAR KNIFE, DISPOSABLE #TM-1611
ClassificationKnife, Orthopedic
Applicant ARTHROPEDICS, INC. 111 LESTER ST. Wallington,  NJ  07057
ContactJerry Procopio
CorrespondentJerry Procopio
ARTHROPEDICS, INC. 111 LESTER ST. Wallington,  NJ  07057
Product CodeHTS  
CFR Regulation Number888.4540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-15
Decision Date1987-11-02

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