Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Sterilizer, Steam
510(k) Number K122774
Device Name SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG
Applicant
Sakura Seiki Co., Ltd.
46-1, Shinden
Chikuma, Nagano,  JP 387-0018
Applicant Contact MARIA GRIFFIN
Correspondent
Tuv Sud America, Inc.
1775 Old Highway 8 NW
New Brighton,  MN  55112 -1891
Regulation Number880.6880
Classification Product Code
FLE  
Date Received09/10/2012
Decision Date 05/09/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-