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FDA 510(k)

STERILE INFUSION SET TYPE S

K-Number: K780655 · 1978-07-19

ApplicantSuru Chemicals & Pharmaceuticals, Ltd.
Decision Date1978-07-19
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERILE INFUSION SET TYPE S is the device name listed in this FDA 510(k) record. The listed applicant is Suru Chemicals & Pharmaceuticals, Ltd.. It received FDA 510(k) clearance on 1978-07-19 under 510(k) number K780655. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE INFUSION SET TYPE S?

STERILE INFUSION SET TYPE S is a medical device that received FDA 510(k) clearance on 1978-07-19. The listed applicant is Suru Chemicals & Pharmaceuticals, Ltd.. The 510(k) number is K780655.

When did STERILE INFUSION SET TYPE S receive FDA 510(k) clearance?

STERILE INFUSION SET TYPE S received FDA 510(k) clearance on 1978-07-19, under 510(k) number K780655.

Who is the listed applicant for STERILE INFUSION SET TYPE S?

The FDA 510(k) record lists Suru Chemicals & Pharmaceuticals, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE INFUSION SET TYPE S?

The FDA product code for STERILE INFUSION SET TYPE S is FPA.

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Other records listing Suru Chemicals & Pharmaceuticals, Ltd. 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.

K811006SOLUTION ADMINISTRATION SETK802169SURU INFUSION SET TYPE JK802170SURU BLOOD COLLECTION SETK780658STERILE BLOOD ADMINISTRATION SETK780657STERILE BLOOD COLLECTION SETK780656STERILE INFUSION SET TYPE J

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Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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