Cleared Traditional

COTTON ROLLS, NON-STERILE

K863764 · The Medical Group, Inc. · Dental
Oct 1986
Decision
32d
Days
Class 1
Risk

About This 510(k) Submission

K863764 is an FDA 510(k) clearance for the COTTON ROLLS, NON-STERILE, a Cotton, Roll (Class I — General Controls, product code EFN), submitted by The Medical Group, Inc. (Reno, US). The FDA issued a Cleared decision on October 27, 1986, 32 days after receiving the submission on September 25, 1986. This device falls under the Dental review panel. Regulated under 21 CFR 872.6050.

Submission Details

510(k) Number K863764 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 1986
Decision Date October 27, 1986
Days to Decision 32 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EFN — Cotton, Roll
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6050

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