LATEX ULTRASONIC PROBE COVER


Device Classification Name

transducer, ultrasonic, diagnostic

510(k) Number K022156
Device Name LATEX ULTRASONIC PROBE COVER
Original Applicant
PLEASURE LATEX PRODUCTS SDN. BHD.
lot 1365, 17th miles, jalan
sungai sembilang
jeram, selangor darul ehsan, 

MY

45800

Original Contact koi-yong lim
Regulation Number 892.1570
Classification Product Code
ITX  
Date Received 07/02/2002
Decision Date 09/11/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Abbreviated
Reviewed by Third Party No

Combination Product

No