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FDA 510(k)

NOVOPEN SYSTEM (INSULIN SYRINGE)

K-Number: K861686 · 1987-01-21

ApplicantSquibb-Novo, Inc.
Decision Date1987-01-21
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NOVOPEN SYSTEM (INSULIN SYRINGE) is the device name listed in this FDA 510(k) record. The listed applicant is Squibb-Novo, Inc.. It received FDA 510(k) clearance on 1987-01-21 under 510(k) number K861686. 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 NOVOPEN SYSTEM (INSULIN SYRINGE)?

NOVOPEN SYSTEM (INSULIN SYRINGE) is a medical device that received FDA 510(k) clearance on 1987-01-21. The listed applicant is Squibb-Novo, Inc.. The 510(k) number is K861686.

When did NOVOPEN SYSTEM (INSULIN SYRINGE) receive FDA 510(k) clearance?

NOVOPEN SYSTEM (INSULIN SYRINGE) received FDA 510(k) clearance on 1987-01-21, under 510(k) number K861686.

Who is the listed applicant for NOVOPEN SYSTEM (INSULIN SYRINGE)?

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

What is the FDA product code for NOVOPEN SYSTEM (INSULIN SYRINGE)?

The FDA product code for NOVOPEN SYSTEM (INSULIN SYRINGE) is FMF.

Related Clinical Trials

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Other records listing Squibb-Novo, 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.

K872805NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY SYSTEM

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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