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FDA 510(k)

MICROCYN SCAR MANAGEMENT HYDROGEL

K-Number: K131672 · 2013-11-15

ApplicantOculus Innovative Sciences
Decision Date2013-11-15
Product CodePFP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICROCYN SCAR MANAGEMENT HYDROGEL is the device name listed in this FDA 510(k) record. The listed applicant is Oculus Innovative Sciences. It received FDA 510(k) clearance on 2013-11-15 under 510(k) number K131672. The device is classified under product code PFP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROCYN SCAR MANAGEMENT HYDROGEL?

MICROCYN SCAR MANAGEMENT HYDROGEL is a medical device that received FDA 510(k) clearance on 2013-11-15. The listed applicant is Oculus Innovative Sciences. The 510(k) number is K131672.

When did MICROCYN SCAR MANAGEMENT HYDROGEL receive FDA 510(k) clearance?

MICROCYN SCAR MANAGEMENT HYDROGEL received FDA 510(k) clearance on 2013-11-15, under 510(k) number K131672.

Who is the listed applicant for MICROCYN SCAR MANAGEMENT HYDROGEL?

The FDA 510(k) record lists Oculus Innovative Sciences as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROCYN SCAR MANAGEMENT HYDROGEL?

The FDA product code for MICROCYN SCAR MANAGEMENT HYDROGEL is PFP.

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Other records listing Oculus Innovative Sciences as applicant

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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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