ULTRA ZYME PLUS AMYL #64982 & 65031

Saccharogenic, Amylase

HARLECO

The following data is part of a premarket notification filed by Harleco with the FDA for Ultra Zyme Plus Amyl #64982 & 65031.

Pre-market Notification Details

Device IDK812594
510k NumberK812594
Device Name:ULTRA ZYME PLUS AMYL #64982 & 65031
ClassificationSaccharogenic, Amylase
Applicant HARLECO 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCIJ  
CFR Regulation Number862.1070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-09-11
Decision Date1981-10-02

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