HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME


Device Classification Name

unit, cryosurgical, accessories

510(k) Number K023487
Device Name HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME
Original Applicant
ORASURE TECHNOLOGIES, INC.
150 webster st.
bethelehem, 
PA 
18015 -1389

Original Contact r. sam niedbala
Regulation Number 878.4350
Classification Product Code
GEH  
Date Received 10/17/2002
Decision Date 03/20/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No