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FDA 510(k)

PROGUARD II(TM)

K-Number: K896086 · 1990-01-24

ApplicantSafety-Ject, Inc.
Decision Date1990-01-24
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROGUARD II(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Safety-Ject, Inc.. It received FDA 510(k) clearance on 1990-01-24 under 510(k) number K896086. 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 PROGUARD II(TM)?

PROGUARD II(TM) is a medical device that received FDA 510(k) clearance on 1990-01-24. The listed applicant is Safety-Ject, Inc.. The 510(k) number is K896086.

When did PROGUARD II(TM) receive FDA 510(k) clearance?

PROGUARD II(TM) received FDA 510(k) clearance on 1990-01-24, under 510(k) number K896086.

Who is the listed applicant for PROGUARD II(TM)?

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

What is the FDA product code for PROGUARD II(TM)?

The FDA product code for PROGUARD II(TM) is FMF.

Related Clinical Trials

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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Other records listing Safety-Ject, 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.

K904295PROGUARD(TM) BLOOD COLLECTION NEEDLE

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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