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 K962755
Device Name STRYKER ENCORE STERILIZER
Applicant
Stryker Corp.
Medical Div.
6300 Sprinkle Rd.
Kalamazoo,  MI  49001 -6197
Applicant Contact CHAD COBERLY
Correspondent
Stryker Corp.
Medical Div.
6300 Sprinkle Rd.
Kalamazoo,  MI  49001 -6197
Correspondent Contact CHAD COBERLY
Regulation Number880.6880
Classification Product Code
FLE  
Date Received07/16/1996
Decision Date 03/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-