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FDA 510(k)

SYNVITRO CUMULASE (HYALURONIDASE MEDIUM)

K-Number: K060699 · 2006-05-10

ApplicantMedicult A/S
Decision Date2006-05-10
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SYNVITRO CUMULASE (HYALURONIDASE MEDIUM) is the device name listed in this FDA 510(k) record. The listed applicant is Medicult A/S. It received FDA 510(k) clearance on 2006-05-10 under 510(k) number K060699. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNVITRO CUMULASE (HYALURONIDASE MEDIUM)?

SYNVITRO CUMULASE (HYALURONIDASE MEDIUM) is a medical device that received FDA 510(k) clearance on 2006-05-10. The listed applicant is Medicult A/S. The 510(k) number is K060699.

When did SYNVITRO CUMULASE (HYALURONIDASE MEDIUM) receive FDA 510(k) clearance?

SYNVITRO CUMULASE (HYALURONIDASE MEDIUM) received FDA 510(k) clearance on 2006-05-10, under 510(k) number K060699.

Who is the listed applicant for SYNVITRO CUMULASE (HYALURONIDASE MEDIUM)?

The FDA 510(k) record lists Medicult A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNVITRO CUMULASE (HYALURONIDASE MEDIUM)?

The FDA product code for SYNVITRO CUMULASE (HYALURONIDASE MEDIUM) is MQL.

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Related Devices (Code: MQL)

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

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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