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FDA 510(k)

IRRIGATION PISTON

K-Number: K803204 · 1981-01-21

ApplicantWalpak Co.
Decision Date1981-01-21
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IRRIGATION PISTON is the device name listed in this FDA 510(k) record. The listed applicant is Walpak Co.. It received FDA 510(k) clearance on 1981-01-21 under 510(k) number K803204. 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 IRRIGATION PISTON?

IRRIGATION PISTON is a medical device that received FDA 510(k) clearance on 1981-01-21. The listed applicant is Walpak Co.. The 510(k) number is K803204.

When did IRRIGATION PISTON receive FDA 510(k) clearance?

IRRIGATION PISTON received FDA 510(k) clearance on 1981-01-21, under 510(k) number K803204.

Who is the listed applicant for IRRIGATION PISTON?

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

What is the FDA product code for IRRIGATION PISTON?

The FDA product code for IRRIGATION PISTON is FMF.

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Other records listing Walpak 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.

K803200IRRIGATION SET W/BULB SYRINGEK803198IRRIGATION SET W/PISTON SYRINGEK803199SUTURE REMOVAL KITK803201LEMON GLYCERINE SWABSK802083CATHETER INSERTION TRAYK791598CLOSED SYSTEM FOLEY CATHERIZATION PROCED

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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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