SPSMEDICAL SPORVIEW STEAM BI


Device Classification Name

indicator, biological sterilization process

510(k) Number K111515
Device Name SPSMEDICAL SPORVIEW STEAM BI
Applicant
SPS MEDICAL SUPPLY CORP.
6789 west henrietta rd.
rush, 
NY 
14543

Applicant Contact gary j socola
Correspondent
SPS MEDICAL SUPPLY CORP.
6789 west henrietta rd.
rush, 
NY 
14543

Correspodent Contact gary j socola
Regulation Number 880.2800
Classification Product Code
FRC  
Date Received 06/01/2011
Decision Date 02/01/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No