Cleared Traditional

K800749 - IPOCON 7 (FDA 510(k) Clearance)

K800749 · Ipos Luneburg · Physical Medicine device

Jul 1980

Decision

115d

Days

Class 1

Risk

K800749 is an FDA 510(k) clearance for the IPOCON 7. This device is classified as a Bandage, Cast (Class I - General Controls, product code ITG).

Submitted by Ipos Luneburg (Mchenry, US). The FDA issued a Cleared decision on July 28, 1980, 115 days after receiving the submission on April 4, 1980.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3025.

Submission Details

510(k) Number	K800749 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 04, 1980
Decision Date	July 28, 1980
Days to Decision	115 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—