FDA 510(k)

PRO-CLEAN

K-Number: K862367 · 1986-07-08

Decision Date1986-07-08

Product Code

DecisionSubstantially Equivalent

Device Summary

PRO-CLEAN is the device name listed in this FDA 510(k) record. The listed applicant is Dermacare Products, Inc.. It received FDA 510(k) clearance on 1986-07-08 under 510(k) number K862367. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO-CLEAN?

PRO-CLEAN is a medical device that received FDA 510(k) clearance on 1986-07-08. The listed applicant is Dermacare Products, Inc.. The 510(k) number is K862367.

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

PRO-CLEAN received FDA 510(k) clearance on 1986-07-08, under 510(k) number K862367.

Who is the listed applicant for PRO-CLEAN?

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

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Other records listing Dermacare Products, Inc. as applicant

K882494ELAN-E DISPOSALBE DRAPE K882421INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE K871910SURGITEK DISPOSABLE BIPOLAR CORD K863279SURGI-TEK TUBE POSITIONER K863280DERMAMARKER K863278SURGI-WIPES

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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.