SPSMEDICAL SPORVIEW STEAM BI TEST PACK


Device Classification Name

indicator, biological sterilization process

510(k) Number K022706
Device Name SPSMEDICAL SPORVIEW STEAM BI TEST PACK
Original Applicant
SPS MEDICAL SUPPLY CORP.
6789 west henrietta rd.
rush, 
NY 
14543

Original Contact gary j socola
Regulation Number 880.2800
Classification Product Code
FRC  
Date Received 08/14/2002
Decision Date 10/25/2002
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