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FDA 510(k)

SAF-T-SYRINGE- 0.5 AND 1ML/CC

K-Number: K063340 · 2007-03-06

ApplicantSafety Medical International, Incorporated
Decision Date2007-03-06
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAF-T-SYRINGE- 0.5 AND 1ML/CC is the device name listed in this FDA 510(k) record. The listed applicant is Safety Medical International, Incorporated. It received FDA 510(k) clearance on 2007-03-06 under 510(k) number K063340. 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 SAF-T-SYRINGE- 0.5 AND 1ML/CC?

SAF-T-SYRINGE- 0.5 AND 1ML/CC is a medical device that received FDA 510(k) clearance on 2007-03-06. The listed applicant is Safety Medical International, Incorporated. The 510(k) number is K063340.

When did SAF-T-SYRINGE- 0.5 AND 1ML/CC receive FDA 510(k) clearance?

SAF-T-SYRINGE- 0.5 AND 1ML/CC received FDA 510(k) clearance on 2007-03-06, under 510(k) number K063340.

Who is the listed applicant for SAF-T-SYRINGE- 0.5 AND 1ML/CC?

The FDA 510(k) record lists Safety Medical International, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAF-T-SYRINGE- 0.5 AND 1ML/CC?

The FDA product code for SAF-T-SYRINGE- 0.5 AND 1ML/CC is MEG.

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Other records listing Safety Medical International, Incorporated 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.

K051762SAF-T-SYRINGE/SAF-T-NEEDLE

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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