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FDA 510(k)

CRYOBAG, MODEL CB

K-Number: K021702 · 2002-08-06

ApplicantOrigen Biomedical, Inc.
Decision Date2002-08-06
Product CodeLPZ
DecisionSubstantially Equivalent

Device Summary

CRYOBAG, MODEL CB is the device name listed in this FDA 510(k) record. The listed applicant is Origen Biomedical, Inc.. It received FDA 510(k) clearance on 2002-08-06 under 510(k) number K021702. The device is classified under product code LPZ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYOBAG, MODEL CB?

CRYOBAG, MODEL CB is a medical device that received FDA 510(k) clearance on 2002-08-06. The listed applicant is Origen Biomedical, Inc.. The 510(k) number is K021702.

When did CRYOBAG, MODEL CB receive FDA 510(k) clearance?

CRYOBAG, MODEL CB received FDA 510(k) clearance on 2002-08-06, under 510(k) number K021702.

Who is the listed applicant for CRYOBAG, MODEL CB?

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

What is the FDA product code for CRYOBAG, MODEL CB?

The FDA product code for CRYOBAG, MODEL CB is LPZ.

Related Clinical Trials

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.

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Other records listing Origen Biomedical, 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.

K113869ORIGEN REINFORCED DUAL LUMEN CATHETERK003288ORIGEN DUAL LUMEN CATHETERK003145ORIGEN BLADDER HOLDER

Related Devices (Code: LPZ)

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.

K915471CRYOBAGJanus Biomedical, Inc.K863872TAMPER HAMPERHydro-Med Products, Inc.K861761ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGETravenol Laboratories, S.A.K860511AMPU-PAKAmmerman Medical Enterprises, Inc.K853663ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STORTravenol Laboratories, S.A.

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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