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FDA 510(k)

CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML

K-Number: K072037 · 2007-08-08

ApplicantLife-Shield Products, Inc.
Decision Date2007-08-08
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML is the device name listed in this FDA 510(k) record. The listed applicant is Life-Shield Products, Inc.. It received FDA 510(k) clearance on 2007-08-08 under 510(k) number K072037. 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 CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML?

CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML is a medical device that received FDA 510(k) clearance on 2007-08-08. The listed applicant is Life-Shield Products, Inc.. The 510(k) number is K072037.

When did CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML receive FDA 510(k) clearance?

CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML received FDA 510(k) clearance on 2007-08-08, under 510(k) number K072037.

Who is the listed applicant for CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML?

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

What is the FDA product code for CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML?

The FDA product code for CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Life-Shield 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.

K061055CAREO SAFETY SYRINGE FOR U-100 INSULINK060208CAREO SAFETY SYRINGE 1CC/ML, MODELS CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C,K052397CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML)K030976CAREO RETRACTABLE 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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