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FDA 510(k)

ASIK 'ONCE' SYRINGE

K-Number: K852444 · 1985-10-16

ApplicantPharma-Plast USA, Inc.
Decision Date1985-10-16
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ASIK 'ONCE' SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Pharma-Plast USA, Inc.. It received FDA 510(k) clearance on 1985-10-16 under 510(k) number K852444. 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 ASIK 'ONCE' SYRINGE?

ASIK 'ONCE' SYRINGE is a medical device that received FDA 510(k) clearance on 1985-10-16. The listed applicant is Pharma-Plast USA, Inc.. The 510(k) number is K852444.

When did ASIK 'ONCE' SYRINGE receive FDA 510(k) clearance?

ASIK 'ONCE' SYRINGE received FDA 510(k) clearance on 1985-10-16, under 510(k) number K852444.

Who is the listed applicant for ASIK 'ONCE' SYRINGE?

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

What is the FDA product code for ASIK 'ONCE' SYRINGE?

The FDA product code for ASIK 'ONCE' SYRINGE is FMF.

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Other records listing Pharma-Plast USA, Inc. as applicant

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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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