Cleared Traditional

DECALCIFYING SOLUTION II

K881359 · Stephens Scientific · General & Plastic Surgery
Apr 1988
Decision
19d
Days
Class 1
Risk

About This 510(k) Submission

K881359 is an FDA 510(k) clearance for the DECALCIFYING SOLUTION II, a Solvent, Adhesive Tape (Class I — General Controls, product code KOX), submitted by Stephens Scientific (Denville, US). The FDA issued a Cleared decision on April 19, 1988, 19 days after receiving the submission on March 31, 1988. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4730.

Submission Details

510(k) Number K881359 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 1988
Decision Date April 19, 1988
Days to Decision 19 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code KOX — Solvent, Adhesive Tape
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4730