Cleared Traditional

STRUNG NEURO SPONGE PATTIES-X-RAY-

K831914 · Ormed Mfg., Inc. · General & Plastic Surgery

Oct 1983

Decision

139d

Days

Class 1

Risk

About This 510(k) Submission

K831914 is an FDA 510(k) clearance for the STRUNG NEURO SPONGE PATTIES-X-RAY-, a Gauze/sponge, Internal, X-ray Detectable (Class I — General Controls, product code GDY), submitted by Ormed Mfg., Inc. (Walker, US). The FDA issued a Cleared decision on October 31, 1983, 139 days after receiving the submission on June 14, 1983. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4450.

Submission Details

510(k) Number	K831914 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 14, 1983
Decision Date	October 31, 1983
Days to Decision	139 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—