BICARBONATE PROCEDURE

Enzymatic, Carbon-dioxide

DATA MEDICAL ASSOCIATES, INC.

The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Bicarbonate Procedure.

Pre-market Notification Details

Device IDK861673
510k NumberK861673
Device Name:BICARBONATE PROCEDURE
ClassificationEnzymatic, Carbon-dioxide
Applicant DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington,  TX  76011
ContactJerry A Graham
CorrespondentJerry A Graham
DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington,  TX  76011
Product CodeKHS  
CFR Regulation Number862.1160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-04-30
Decision Date1986-07-01

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