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FDA 510(k)

CRYOCYTE PACK

K-Number: K780354 · 1978-06-14

ApplicantTravenol Laboratories, S.A.
Decision Date1978-06-14
Product CodeKSR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CRYOCYTE PACK is the device name listed in this FDA 510(k) record. The listed applicant is Travenol Laboratories, S.A.. It received FDA 510(k) clearance on 1978-06-14 under 510(k) number K780354. 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 CRYOCYTE PACK?

CRYOCYTE PACK is a medical device that received FDA 510(k) clearance on 1978-06-14. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K780354.

When did CRYOCYTE PACK receive FDA 510(k) clearance?

CRYOCYTE PACK received FDA 510(k) clearance on 1978-06-14, under 510(k) number K780354.

Who is the listed applicant for CRYOCYTE PACK?

The FDA 510(k) record lists Travenol Laboratories, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRYOCYTE PACK?

The FDA product code for CRYOCYTE PACK is KSR.

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Other records listing Travenol Laboratories, S.A. 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.

K874181BAXTER BEDSIDE SYSTEMK873894CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITEK873873RESUBMITTED MICRON TRANSFUSION FILTERK873984AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)K872364HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309K872652UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM

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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.

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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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