ORIBRUSH – WITH PROTECTIVE TIP – B001


Device Classification Name

spatula, cervical, cytological

510(k) Number K991595
Device Name ORIBRUSH – WITH PROTECTIVE TIP – B001
Applicant
ORIFICE MEDICAL AB
bronsgatan 12
ystad, 

SE

s-271 39

Applicant Contact patric nilsson
Correspondent
ORIFICE MEDICAL AB
bronsgatan 12
ystad, 

SE

s-271 39

Correspodent Contact patric nilsson
Regulation Number 884.4530
Classification Product Code
HHT  
Date Received 05/07/1999
Decision Date 06/29/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No