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FDA 510(k)

ICC INSULIN SAFEPRO SAFETY SYRINGE

K-Number: K050134 · 2005-04-05

ApplicantFormosa Medical Devices, Inc.
Decision Date2005-04-05
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ICC INSULIN SAFEPRO SAFETY SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Formosa Medical Devices, Inc.. It received FDA 510(k) clearance on 2005-04-05 under 510(k) number K050134. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICC INSULIN SAFEPRO SAFETY SYRINGE?

ICC INSULIN SAFEPRO SAFETY SYRINGE is a medical device that received FDA 510(k) clearance on 2005-04-05. The listed applicant is Formosa Medical Devices, Inc.. The 510(k) number is K050134.

When did ICC INSULIN SAFEPRO SAFETY SYRINGE receive FDA 510(k) clearance?

ICC INSULIN SAFEPRO SAFETY SYRINGE received FDA 510(k) clearance on 2005-04-05, under 510(k) number K050134.

Who is the listed applicant for ICC INSULIN SAFEPRO SAFETY SYRINGE?

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

What is the FDA product code for ICC INSULIN SAFEPRO SAFETY SYRINGE?

The FDA product code for ICC INSULIN SAFEPRO SAFETY SYRINGE is MEG.

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 Formosa Medical Devices, 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.

K031830SAFEPRO PLUS SAFETY SYRINGEK022063SAFEPRO SAFETY SYRINGE

Related Devices (Code: MEG)

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.

K252098PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)Methyl Co., Ltd.K250847VaporShieldVault Paragon Group, Inc.K230287SaviSafe Safety DeviceSuzhou Savicred Biotechnology Co., Ltd.K231165Shina Syringe; Shina Safety SyringeShina Med CorporationK231907Medline Safety Insulin and TB SyringesMedline Industries, LPK223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)Cardinal Health200, LLC

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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