Cleared Traditional

K864294 - HENKE-JECT PRESSURE SYRINGE (MODIFICATION)
(FDA 510(k) Clearance)

K864294 · Smith & Nephew, Inc. · Dental device

Nov 1987

Decision

369d

Days

Class 2

Risk

K864294 is an FDA 510(k) clearance for the HENKE-JECT PRESSURE SYRINGE (MODIFICATION). This device is classified as a Injector, Jet, Mechanical-powered (Class II - Special Controls, product code EGM).

Submitted by Smith & Nephew, Inc. (Chicago, US). The FDA issued a Cleared decision on November 4, 1987, 369 days after receiving the submission on October 31, 1986.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4475.

Submission Details

510(k) Number	K864294 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 31, 1986
Decision Date	November 04, 1987
Days to Decision	369 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—