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FDA 510(k)

SYRINGE, PISTON

K-Number: K821528 · 1982-06-09

ApplicantMedcare Disp Products, Inc.
Decision Date1982-06-09
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SYRINGE, PISTON is the device name listed in this FDA 510(k) record. The listed applicant is Medcare Disp Products, Inc.. It received FDA 510(k) clearance on 1982-06-09 under 510(k) number K821528. 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 SYRINGE, PISTON?

SYRINGE, PISTON is a medical device that received FDA 510(k) clearance on 1982-06-09. The listed applicant is Medcare Disp Products, Inc.. The 510(k) number is K821528.

When did SYRINGE, PISTON receive FDA 510(k) clearance?

SYRINGE, PISTON received FDA 510(k) clearance on 1982-06-09, under 510(k) number K821528.

Who is the listed applicant for SYRINGE, PISTON?

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

What is the FDA product code for SYRINGE, PISTON?

The FDA product code for SYRINGE, PISTON is FMF.

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Other records listing Medcare Disp Products, 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.

K841949DOSE RELEASE OF STERILIZATION LOTSK841405INJECTION CAP OR ADAPTORK840924SYRINGE, PISTON, ARTERIAL BLOOD SAMPLK821529DISPOSABLE HYPODERMIC NEEDLESK821530SYRINGE IRRIGATING

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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