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FDA 510(k)

REVAC AUTO RETRACTABLE SAFETY SYRINGE

K-Number: K083193 · 2009-02-13

ApplicantRevolutions Medical Corporation, Inc.
Decision Date2009-02-13
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

REVAC AUTO RETRACTABLE SAFETY SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Revolutions Medical Corporation, Inc.. It received FDA 510(k) clearance on 2009-02-13 under 510(k) number K083193. 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 REVAC AUTO RETRACTABLE SAFETY SYRINGE?

REVAC AUTO RETRACTABLE SAFETY SYRINGE is a medical device that received FDA 510(k) clearance on 2009-02-13. The listed applicant is Revolutions Medical Corporation, Inc.. The 510(k) number is K083193.

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

REVAC AUTO RETRACTABLE SAFETY SYRINGE received FDA 510(k) clearance on 2009-02-13, under 510(k) number K083193.

Who is the listed applicant for REVAC AUTO RETRACTABLE SAFETY SYRINGE?

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

What is the FDA product code for REVAC AUTO RETRACTABLE SAFETY SYRINGE?

The FDA product code for REVAC AUTO RETRACTABLE SAFETY SYRINGE is FMF.

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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.

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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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