ULTRA-KLEEN POWDER FOR DENTAL UNIT WATER LINES, MODELS 513P, 505L


Device Classification Name

unit, operative dental

510(k) Number K991946
Device Name ULTRA-KLEEN POWDER FOR DENTAL UNIT WATER LINES, MODELS 513P, 505L
Applicant
STERILEX CORP.
7-i gwynns hill court
owins mills, 
MD 
21117

Applicant Contact shira kramer
Correspondent
STERILEX CORP.
7-i gwynns hill court
owins mills, 
MD 
21117

Correspodent Contact shira kramer
Regulation Number 872.6640
Classification Product Code
EIA  
Date Received 06/09/1999
Decision Date 09/03/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No