SALIVA SUBSTITUTE

Saliva, Artificial

ROXANE LABORATORIES, INC.

The following data is part of a premarket notification filed by Roxane Laboratories, Inc. with the FDA for Saliva Substitute.

Pre-market Notification Details

Device IDK822971
510k NumberK822971
Device Name:SALIVA SUBSTITUTE
ClassificationSaliva, Artificial
Applicant ROXANE LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLFD  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-10-08
Decision Date1982-11-16

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