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FDA 510(k)

PHARMAFLEX CRYOGENIC BAG

K-Number: K792395 · 1980-02-26

ApplicantPharmachem Corp.
Decision Date1980-02-26
Product CodeKSR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PHARMAFLEX CRYOGENIC BAG is the device name listed in this FDA 510(k) record. The listed applicant is Pharmachem Corp.. It received FDA 510(k) clearance on 1980-02-26 under 510(k) number K792395. The device is classified under product code KSR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHARMAFLEX CRYOGENIC BAG?

PHARMAFLEX CRYOGENIC BAG is a medical device that received FDA 510(k) clearance on 1980-02-26. The listed applicant is Pharmachem Corp.. The 510(k) number is K792395.

When did PHARMAFLEX CRYOGENIC BAG receive FDA 510(k) clearance?

PHARMAFLEX CRYOGENIC BAG received FDA 510(k) clearance on 1980-02-26, under 510(k) number K792395.

Who is the listed applicant for PHARMAFLEX CRYOGENIC BAG?

The FDA 510(k) record lists Pharmachem Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHARMAFLEX CRYOGENIC BAG?

The FDA product code for PHARMAFLEX CRYOGENIC BAG is KSR.

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Related Devices (Code: KSR)

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.

K032827KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501Tyco HealthcareK020753DEROYAL SURGICAL, UMBILICUPDeroyalK810897ALPHA PLASTIC PLASMA BOTTLEAlpha Therapeutic Corp.K810500BLOOD FREEZING BAGDelmed, Inc.K811523PLASMA FLEXTerumo America, Inc.K811449HAEMONETICS 1000ML COMPONENT BAGHaemonetics Corp.

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.

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