THREADING TUBE

Guide, Surgical, Instrument

PLASTAFIL, INC.

The following data is part of a premarket notification filed by Plastafil, Inc. with the FDA for Threading Tube.

Pre-market Notification Details

Device IDK841618
510k NumberK841618
Device Name:THREADING TUBE
ClassificationGuide, Surgical, Instrument
Applicant PLASTAFIL, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFZX  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-04-19
Decision Date1984-08-27

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