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FDA 510(k)

SOLO-SAFE SAFETY SYRINGE, SIZE-3CC

K-Number: K003555 · 2001-08-29

ApplicantSpectrum Biotech, Inc.
Decision Date2001-08-29
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SOLO-SAFE SAFETY SYRINGE, SIZE-3CC is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Biotech, Inc.. It received FDA 510(k) clearance on 2001-08-29 under 510(k) number K003555. 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 SOLO-SAFE SAFETY SYRINGE, SIZE-3CC?

SOLO-SAFE SAFETY SYRINGE, SIZE-3CC is a medical device that received FDA 510(k) clearance on 2001-08-29. The listed applicant is Spectrum Biotech, Inc.. The 510(k) number is K003555.

When did SOLO-SAFE SAFETY SYRINGE, SIZE-3CC receive FDA 510(k) clearance?

SOLO-SAFE SAFETY SYRINGE, SIZE-3CC received FDA 510(k) clearance on 2001-08-29, under 510(k) number K003555.

Who is the listed applicant for SOLO-SAFE SAFETY SYRINGE, SIZE-3CC?

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

What is the FDA product code for SOLO-SAFE SAFETY SYRINGE, SIZE-3CC?

The FDA product code for SOLO-SAFE SAFETY SYRINGE, SIZE-3CC is MEG.

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Related Devices (Code: MEG)

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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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