Cleared Traditional

K802833 - TETRA NATAL-MAT WATER FLOTATION MAT.
(FDA 510(k) Clearance)

K802833 · Tetra Group U.S.A., Inc. · General Hospital

Dec 1980

Decision

28d

Days

Class 1

Risk

K802833 is an FDA 510(k) clearance for the TETRA NATAL-MAT WATER FLOTATION MAT.. This device is classified as a Mattress, Flotation Therapy, Non-powered (Class I - General Controls, product code IKY).

Submitted by Tetra Group U.S.A., Inc. (Mchenry, US). The FDA issued a Cleared decision on December 10, 1980, 28 days after receiving the submission on November 12, 1980.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5150.

Submission Details

510(k) Number	K802833 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 12, 1980
Decision Date	December 10, 1980
Days to Decision	28 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—