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FDA 510(k)

OMI RETRACTABLE SAFETY SYRINGE

K-Number: K060109 · 2006-05-05

ApplicantVitalcare Group, Inc.
Decision Date2006-05-05
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OMI RETRACTABLE SAFETY SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Vitalcare Group, Inc.. It received FDA 510(k) clearance on 2006-05-05 under 510(k) number K060109. 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 OMI RETRACTABLE SAFETY SYRINGE?

OMI RETRACTABLE SAFETY SYRINGE is a medical device that received FDA 510(k) clearance on 2006-05-05. The listed applicant is Vitalcare Group, Inc.. The 510(k) number is K060109.

When did OMI RETRACTABLE SAFETY SYRINGE receive FDA 510(k) clearance?

OMI RETRACTABLE SAFETY SYRINGE received FDA 510(k) clearance on 2006-05-05, under 510(k) number K060109.

Who is the listed applicant for OMI RETRACTABLE SAFETY SYRINGE?

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

What is the FDA product code for OMI RETRACTABLE SAFETY SYRINGE?

The FDA product code for OMI RETRACTABLE SAFETY SYRINGE is MEG.

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Other records listing Vitalcare Group, 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.

K050906VITALCARE I.V. ADMINISTRATION SETK040916VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVEK031748VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGESK992289VINYL POWDERED EXAM GLOVE / CAT.# 15-020K983016GAUZE, SPONGES, CAT # 11-003K983716VITALCARE DISPOSABLE VAGINAL SPECULUM

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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

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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