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510(k) K933619

Device
PD-PAK
Applicant
GENERAL MEDICAL MFG. CO.
510(k) number
K933619
Product code
MLW  
Decision
Substantially Equivalent (SESE)
Decision date
1994-02-22
Date received
1993-07-19
Regulation
876.5630
Classification name
Warmer, Peritoneal Dialysate
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ALFRED H GREBE
Address
8741 Landmark Rd. Richmond VA US 23228 23228

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MLW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240447ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)Thermasolutions, LLC2025-05-05
K131583THERMOCHEM HT-2000Thermasolutions, Inc.2013-10-03
K020542DAYTRIPPER DIALYSATE WARMERStickman Industries, Inc.2002-09-27
K993330THERMOCHEM-HT SYSTEMHemocleanse, Inc.1999-12-30
K964825FREEDOM TRAVELLERImpact Case Technologies, Inc.1997-05-19

Legacy Summary#

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FDA Review#

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