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FDA 510(k)

MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES

K-Number: K922522 · 1992-11-25

ApplicantSherwood Medical Co.
Decision Date1992-11-25
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES is the device name listed in this FDA 510(k) record. The listed applicant is Sherwood Medical Co.. It received FDA 510(k) clearance on 1992-11-25 under 510(k) number K922522. 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 MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES?

MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES is a medical device that received FDA 510(k) clearance on 1992-11-25. The listed applicant is Sherwood Medical Co.. The 510(k) number is K922522.

When did MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES receive FDA 510(k) clearance?

MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES received FDA 510(k) clearance on 1992-11-25, under 510(k) number K922522.

Who is the listed applicant for MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES?

The FDA 510(k) record lists Sherwood Medical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES?

The FDA product code for MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES is FMF.

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Other records listing Sherwood Medical Co. 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.

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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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