SURGITEK MEDI-LOOPS

Instrument, Surgical, Disposable

MEDICAL ENGINEERING CORP.

The following data is part of a premarket notification filed by Medical Engineering Corp. with the FDA for Surgitek Medi-loops.

Pre-market Notification Details

Device IDK803156
510k NumberK803156
Device Name:SURGITEK MEDI-LOOPS
ClassificationInstrument, Surgical, Disposable
Applicant MEDICAL ENGINEERING CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKDC  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-12-12
Decision Date1981-01-15

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