PD-PAK

Warmer, Peritoneal Dialysate

GENERAL MEDICAL MFG. CO.

The following data is part of a premarket notification filed by General Medical Mfg. Co. with the FDA for Pd-pak.

Pre-market Notification Details

Device IDK933619
510k NumberK933619
Device Name:PD-PAK
ClassificationWarmer, Peritoneal Dialysate
Applicant GENERAL MEDICAL MFG. CO. 8741 LANDMARK RD. Richmond,  VA  23228
ContactAlfred H Grebe
CorrespondentAlfred H Grebe
GENERAL MEDICAL MFG. CO. 8741 LANDMARK RD. Richmond,  VA  23228
Product CodeMLW  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-07-19
Decision Date1994-02-22

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