10% NEUTRAL BUFFERED FORMALDEHYDE

Formalin, Neutral Buffered

RICHARD-ALLAN MEDICAL IND., INC.

The following data is part of a premarket notification filed by Richard-allan Medical Ind., Inc. with the FDA for 10% Neutral Buffered Formaldehyde.

Pre-market Notification Details

Device IDK811795
510k NumberK811795
Device Name:10% NEUTRAL BUFFERED FORMALDEHYDE
ClassificationFormalin, Neutral Buffered
Applicant RICHARD-ALLAN MEDICAL IND., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeIFP  
CFR Regulation Number864.4010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-06-24
Decision Date1981-07-28

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