Cleared Traditional

ULTRA-PAN FOR ORTHOTIC PLASTICS (7262)

K880644 · Fred Sammons, Inc. · Physical Medicine
May 1988
Decision
80d
Days
Class 1
Risk

About This 510(k) Submission

K880644 is an FDA 510(k) clearance for the ULTRA-PAN FOR ORTHOTIC PLASTICS (7262), a Unit, Heating, Powered (Class I — General Controls, product code IRQ), submitted by Fred Sammons, Inc. (Burr Ridge, US). The FDA issued a Cleared decision on May 6, 1988, 80 days after receiving the submission on February 16, 1988. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5950.

Submission Details

510(k) Number K880644 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 1988
Decision Date May 06, 1988
Days to Decision 80 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code IRQ — Unit, Heating, Powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5950

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