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FDA 510(k)

BLOOD FREEZING BAG

K-Number: K810500 · 1981-09-23

ApplicantDelmed, Inc.
Decision Date1981-09-23
Product CodeKSR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BLOOD FREEZING BAG is the device name listed in this FDA 510(k) record. The listed applicant is Delmed, Inc.. It received FDA 510(k) clearance on 1981-09-23 under 510(k) number K810500. 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 BLOOD FREEZING BAG?

BLOOD FREEZING BAG is a medical device that received FDA 510(k) clearance on 1981-09-23. The listed applicant is Delmed, Inc.. The 510(k) number is K810500.

When did BLOOD FREEZING BAG receive FDA 510(k) clearance?

BLOOD FREEZING BAG received FDA 510(k) clearance on 1981-09-23, under 510(k) number K810500.

Who is the listed applicant for BLOOD FREEZING BAG?

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

What is the FDA product code for BLOOD FREEZING BAG?

The FDA product code for BLOOD FREEZING BAG is KSR.

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Other records listing Delmed, Inc. as applicant

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.

K895142ENTERAL PUMP SET WITH ENTERAL SPIKEK895650ENTERAL PUMP SET W/ENTERA-FLO SPIKEK895329600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERAK894506ENTERA-FLO ENTERAL FEEDING PUMPK901478DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTIONK901477DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION

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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.K811523PLASMA FLEXTerumo America, Inc.K811449HAEMONETICS 1000ML COMPONENT BAGHaemonetics Corp.K810711HAEMONETICS 600 ML. COMPONENT BAGHaemonetics Corp.

Official Source

View on FDA Database →

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

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