Cleared Traditional

SUPERIOR BATH, MODEL 6300

K012061 · Penner Manufacturing, Inc. · Physical Medicine

Jul 2001

Decision

17d

Days

Class 2

Risk

About This 510(k) Submission

K012061 is an FDA 510(k) clearance for the SUPERIOR BATH, MODEL 6300, a Bath, Hydro-massage (Class II — Special Controls, product code ILJ), submitted by Penner Manufacturing, Inc. (Ohaha, US). The FDA issued a Cleared decision on July 19, 2001, 17 days after receiving the submission on July 2, 2001. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5100.

Submission Details

510(k) Number	K012061 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 02, 2001
Decision Date	July 19, 2001
Days to Decision	17 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement