FDA 510(k)

PD-PAK

K-Number: K933619 · 1994-02-22

Decision Date1994-02-22

Product CodeMLW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

PD-PAK is the device name listed in this FDA 510(k) record. The listed applicant is General Medical Mfg. Co.. It received FDA 510(k) clearance on 1994-02-22 under 510(k) number K933619. The device is classified under product code MLW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PD-PAK?

PD-PAK is a medical device that received FDA 510(k) clearance on 1994-02-22. The listed applicant is General Medical Mfg. Co.. The 510(k) number is K933619.

When did PD-PAK receive FDA 510(k) clearance?

PD-PAK received FDA 510(k) clearance on 1994-02-22, under 510(k) number K933619.

Who is the listed applicant for PD-PAK?

The FDA 510(k) record lists General Medical Mfg. Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PD-PAK?

The FDA product code for PD-PAK is MLW.

Related Devices (Code: MLW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240447ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)Thermasolutions, LLC K131583THERMOCHEM HT-2000Thermasolutions, Inc.K020542DAYTRIPPER DIALYSATE WARMERStickman Industries, Inc.K993330THERMOCHEM-HT SYSTEMHemocleanse, Inc.K964825FREEDOM TRAVELLERImpact Case Technologies, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.