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FDA 510(k)

DERMA PREP

K-Number: K851612 · 1985-05-03

ApplicantMowbray Co., Inc.
Decision Date1985-05-03
Product CodeKGT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DERMA PREP is the device name listed in this FDA 510(k) record. The listed applicant is Mowbray Co., Inc.. It received FDA 510(k) clearance on 1985-05-03 under 510(k) number K851612. The device is classified under product code KGT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMA PREP?

DERMA PREP is a medical device that received FDA 510(k) clearance on 1985-05-03. The listed applicant is Mowbray Co., Inc.. The 510(k) number is K851612.

When did DERMA PREP receive FDA 510(k) clearance?

DERMA PREP received FDA 510(k) clearance on 1985-05-03, under 510(k) number K851612.

Who is the listed applicant for DERMA PREP?

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

What is the FDA product code for DERMA PREP?

The FDA product code for DERMA PREP is KGT.

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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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