Cleared Traditional

MOISTURESTAY (REVLON)

K022626 · Raymond Industrial, Ltd. · Physical Medicine

Oct 2002

Decision

83d

Days

Class 2

Risk

About This 510(k) Submission

K022626 is an FDA 510(k) clearance for the MOISTURESTAY (REVLON), a Bath, Paraffin (Class II — Special Controls, product code IMC), submitted by Raymond Industrial, Ltd. (Saint Petersburg, US). The FDA issued a Cleared decision on October 29, 2002, 83 days after receiving the submission on August 7, 2002. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5110.

Submission Details

510(k) Number	K022626 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 07, 2002
Decision Date	October 29, 2002
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement