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FDA 510(k)

DRUG ACCESS SPIKE

K-Number: K051930 · 2005-08-16

ApplicantMedegen Medical Manufacturing Services
Decision Date2005-08-16
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DRUG ACCESS SPIKE is the device name listed in this FDA 510(k) record. The listed applicant is Medegen Medical Manufacturing Services. It received FDA 510(k) clearance on 2005-08-16 under 510(k) number K051930. 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 DRUG ACCESS SPIKE?

DRUG ACCESS SPIKE is a medical device that received FDA 510(k) clearance on 2005-08-16. The listed applicant is Medegen Medical Manufacturing Services. The 510(k) number is K051930.

When did DRUG ACCESS SPIKE receive FDA 510(k) clearance?

DRUG ACCESS SPIKE received FDA 510(k) clearance on 2005-08-16, under 510(k) number K051930.

Who is the listed applicant for DRUG ACCESS SPIKE?

The FDA 510(k) record lists Medegen Medical Manufacturing Services as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRUG ACCESS SPIKE?

The FDA product code for DRUG ACCESS SPIKE is FMF.

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Other records listing Medegen Medical Manufacturing Services as applicant

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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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