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 sterilization wrap containers, trays, cassettes & other accessories
510(k) Number K051157
Device Name INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS
Applicant
MICROMEDICS, INC.
1270 eagan industrial road
suite 120
eagan,  MN  55121
Applicant Contact tom a lopac
Correspondent
MICROMEDICS, INC.
1270 eagan industrial road
suite 120
eagan,  MN  55121
Correspondent Contact tom a lopac
Regulation Number880.6850
Classification Product Code
KCT  
Date Received05/05/2005
Decision Date 09/01/2005
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-