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FDA 510(k)

PRO-V COAT

K-Number: K103514 · 2011-05-25

ApplicantBisco, Inc.
Decision Date2011-05-25
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRO-V COAT is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2011-05-25 under 510(k) number K103514. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO-V COAT?

PRO-V COAT is a medical device that received FDA 510(k) clearance on 2011-05-25. The listed applicant is Bisco, Inc.. The 510(k) number is K103514.

When did PRO-V COAT receive FDA 510(k) clearance?

PRO-V COAT received FDA 510(k) clearance on 2011-05-25, under 510(k) number K103514.

Who is the listed applicant for PRO-V COAT?

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

What is the FDA product code for PRO-V COAT?

The FDA product code for PRO-V COAT is EBG.

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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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