HALIFAX BIOMEDICAL TANATLUM BEAD SET


Device Classification Name

marker, radiographic, implantable

510(k) Number K103417
Device Name HALIFAX BIOMEDICAL TANATLUM BEAD SET
Applicant
HALIFAX BIOMEDICAL, INC.
3 elizabeth place
lake hopatcong, 
NJ 
07849

Applicant Contact robert a poggie, phd
Correspondent
HALIFAX BIOMEDICAL, INC.
3 elizabeth place
lake hopatcong, 
NJ 
07849

Correspodent Contact robert a poggie, phd
Regulation Number 878.4300
Classification Product Code
NEU  
Date Received 11/22/2010
Decision Date 06/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No