Cleared Traditional

GENERAL HYGIENE KIT

K954068 · Physician Industries, Inc. · Dental
Nov 1995
Decision
70d
Days
Class 1
Risk

About This 510(k) Submission

K954068 is an FDA 510(k) clearance for the GENERAL HYGIENE KIT, a Absorber, Saliva, Paper (Class I — General Controls, product code KHR), submitted by Physician Industries, Inc. (North Salt Lake, US). The FDA issued a Cleared decision on November 8, 1995, 70 days after receiving the submission on August 30, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.6050.

Submission Details

510(k) Number K954068 FDA.gov
FDA Decision Cleared SESK
Date Received August 30, 1995
Decision Date November 08, 1995
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code KHR — Absorber, Saliva, Paper
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6050