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FDA 510(k)

PHARMACY ADDITIVE SYRINGE SET

K-Number: K800213 · 1980-02-26

ApplicantCutter Laboratories, Inc.
Decision Date1980-02-26
Product CodeKYW
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PHARMACY ADDITIVE SYRINGE SET is the device name listed in this FDA 510(k) record. The listed applicant is Cutter Laboratories, Inc.. It received FDA 510(k) clearance on 1980-02-26 under 510(k) number K800213. The device is classified under product code KYW. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHARMACY ADDITIVE SYRINGE SET?

PHARMACY ADDITIVE SYRINGE SET is a medical device that received FDA 510(k) clearance on 1980-02-26. The listed applicant is Cutter Laboratories, Inc.. The 510(k) number is K800213.

When did PHARMACY ADDITIVE SYRINGE SET receive FDA 510(k) clearance?

PHARMACY ADDITIVE SYRINGE SET received FDA 510(k) clearance on 1980-02-26, under 510(k) number K800213.

Who is the listed applicant for PHARMACY ADDITIVE SYRINGE SET?

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

What is the FDA product code for PHARMACY ADDITIVE SYRINGE SET?

The FDA product code for PHARMACY ADDITIVE SYRINGE SET is KYW.

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Other records listing Cutter Laboratories, 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.

K861315HYPERBARIC PENETRATION EXTENSION SETK854106BAYSILEXK842324PERFOURMK834106INTRAVENOUS INFUSION CONTROLLERK832237ORTHOPEDIC CASTING TAPE MAXCASTK823214DOSIMETRIC RELEASE PROGRAM - ADMIN. SET

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Related Devices (Code: KYW)

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.

K791345MEDICINE CUPGeneral Clinical Plastics 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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