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FDA 510(k)

RAMY INTEGRATED NEEDLE SYRINGE

K-Number: K972452 · 1997-07-24

ApplicantAlshifa Medical Syringes Mfg. Co., Ltd.
Decision Date1997-07-24
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RAMY INTEGRATED NEEDLE SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Alshifa Medical Syringes Mfg. Co., Ltd.. It received FDA 510(k) clearance on 1997-07-24 under 510(k) number K972452. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAMY INTEGRATED NEEDLE SYRINGE?

RAMY INTEGRATED NEEDLE SYRINGE is a medical device that received FDA 510(k) clearance on 1997-07-24. The listed applicant is Alshifa Medical Syringes Mfg. Co., Ltd.. The 510(k) number is K972452.

When did RAMY INTEGRATED NEEDLE SYRINGE receive FDA 510(k) clearance?

RAMY INTEGRATED NEEDLE SYRINGE received FDA 510(k) clearance on 1997-07-24, under 510(k) number K972452.

Who is the listed applicant for RAMY INTEGRATED NEEDLE SYRINGE?

The FDA 510(k) record lists Alshifa Medical Syringes Mfg. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAMY INTEGRATED NEEDLE SYRINGE?

The FDA product code for RAMY INTEGRATED NEEDLE SYRINGE is FMF.

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 Alshifa Medical Syringes Mfg. Co., 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.

K971664RAMY PISTON SYRINGE

Related Devices (Code: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

Official Source

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

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