Cleared Traditional

PAROJECT ANESTHETIC SYRINGE

K904279 · Ronvig Instruments, Ltd. · Dental

Dec 1990

Decision

81d

Days

Class 2

Risk

About This 510(k) Submission

K904279 is an FDA 510(k) clearance for the PAROJECT ANESTHETIC SYRINGE, a Injector, Jet, Mechanical-powered (Class II — Special Controls, product code EGM), submitted by Ronvig Instruments, Ltd. (Milford, US). The FDA issued a Cleared decision on December 7, 1990, 81 days after receiving the submission on September 17, 1990. This device falls under the Dental review panel. Regulated under 21 CFR 872.4475.

Submission Details

510(k) Number	K904279 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 17, 1990
Decision Date	December 07, 1990
Days to Decision	81 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—