PRO-CLEAN

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la

DERMACARE PRODUCTS, INC.

The following data is part of a premarket notification filed by Dermacare Products, Inc. with the FDA for Pro-clean.

Pre-market Notification Details

• Device ID: K862367
• 510k Number: K862367
• Device Name: PRO-CLEAN
• Classification: 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la
• Applicant: DERMACARE PRODUCTS, INC. 7651 NATIONAL TURNPIKE Louisville, KT 40214
• Contact: Ken Potts
• Correspondent: Ken Potts; DERMACARE PRODUCTS, INC. 7651 NATIONAL TURNPIKE Louisville, KT 40214
• Product Code: 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood &
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-06-24
• Decision Date: 1986-07-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30841785111434	K862367	000
30841785111410	K862367	000