LINK CEMENT PLUG

Cement Obturator

TURNKEY INTERGRATION USA, INC.

The following data is part of a premarket notification filed by Turnkey Intergration Usa, Inc. with the FDA for Link Cement Plug.

Pre-market Notification Details

Device IDK972411
510k NumberK972411
Device Name:LINK CEMENT PLUG
ClassificationCement Obturator
Applicant TURNKEY INTERGRATION USA, INC. 321 PALMER RD. Denville,  NJ  07834
ContactDouglas W Stuart
CorrespondentDouglas W Stuart
TURNKEY INTERGRATION USA, INC. 321 PALMER RD. Denville,  NJ  07834
Product CodeLZN  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-26
Decision Date1997-08-29

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