Cleared Traditional

OMNI-JUG

K952200 · Waterstone Medical, Inc. · General & Plastic Surgery

Jun 1995

Decision

50d

Days

Class 1

Risk

About This 510(k) Submission

K952200 is an FDA 510(k) clearance for the OMNI-JUG, a Chisel (osteotome) (Class I — General Controls, product code KDG), submitted by Waterstone Medical, Inc. (Bethesda, US). The FDA issued a Cleared decision on June 29, 1995, 50 days after receiving the submission on May 10, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K952200 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 10, 1995
Decision Date	June 29, 1995
Days to Decision	50 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement