GETTIG GUARD


the company

Device Classification Name

needle, hypodermic, single lumen

510(k) Number K000455
Device Name GETTIG GUARD
Original Applicant
GETTIG PHARMACEUTICAL INSTRUMENT CO.
55 northern blvd.
suite 200
great neck, 
NY 
11021

Original Contact james a benz
Regulation Number 880.5570
Classification Product Code
FMI  
Date Received 02/11/2000
Decision Date 04/19/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No