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FDA 510(k)

GLASS SYRINGES, DRUG, LUER LOCK

K-Number: K820384 · 1982-04-15

ApplicantProcedure Products, Inc.
Decision Date1982-04-15
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GLASS SYRINGES, DRUG, LUER LOCK is the device name listed in this FDA 510(k) record. The listed applicant is Procedure Products, Inc.. It received FDA 510(k) clearance on 1982-04-15 under 510(k) number K820384. 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 GLASS SYRINGES, DRUG, LUER LOCK?

GLASS SYRINGES, DRUG, LUER LOCK is a medical device that received FDA 510(k) clearance on 1982-04-15. The listed applicant is Procedure Products, Inc.. The 510(k) number is K820384.

When did GLASS SYRINGES, DRUG, LUER LOCK receive FDA 510(k) clearance?

GLASS SYRINGES, DRUG, LUER LOCK received FDA 510(k) clearance on 1982-04-15, under 510(k) number K820384.

Who is the listed applicant for GLASS SYRINGES, DRUG, LUER LOCK?

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

What is the FDA product code for GLASS SYRINGES, DRUG, LUER LOCK?

The FDA product code for GLASS SYRINGES, DRUG, LUER LOCK is FMF.

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Other records listing Procedure Products, Inc. as applicant

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K161812Freedom SyringeK923194INSUFFLATOR CONNECTING FILTERK922536TORQUE DEVICEK914128CONNECTING SETK910673BAG SPIGOTK884985MODIFIED 10CC SYRINGE CONTROL RING SET

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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

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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