Cleared Traditional

PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR

K932333 · Gull Laboratories, Inc. · Dental
Aug 1995
Decision
824d
Days
Class 1
Risk

About This 510(k) Submission

K932333 is an FDA 510(k) clearance for the PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR, a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on August 15, 1995, 824 days after receiving the submission on May 13, 1993. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K932333 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 1993
Decision Date August 15, 1995
Days to Decision 824 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EFB — Handpiece, Air-powered, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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