STEAM DOT BLU PROCESS INDICATOR


Device Classification Name

indicator, physical/chemical sterilization process

510(k) Number K111453
Device Name STEAM DOT BLU PROCESS INDICATOR
Applicant
PROPPER MFG. CO., INC.
36-04 skillman ave.
long island city, 
NY 
11101

Applicant Contact andrew sharavara
Correspondent
PROPPER MFG. CO., INC.
36-04 skillman ave.
long island city, 
NY 
11101

Correspodent Contact andrew sharavara
Regulation Number 880.2800
Classification Product Code
JOJ  
Date Received 05/25/2011
Decision Date 04/05/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No