JEL BIOS 90 (CODE NAME RD-2401)


definition

Device Classification Name

alloy, gold-based noble metal

510(k) Number K001196
Device Name JEL BIOS 90 (CODE NAME RD-2401)
Original Applicant
J.F. JELENKO & CO., INC.
99 business park dr.
armonk, 
NY 
10504

Original Contact raphael judkins
Regulation Number 872.3060
Classification Product Code
EJT  
Date Received 04/12/2000
Decision Date 05/11/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No