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 Tissue Expander And Accessories
510(k) Number K894495
Device Name SURGITEK(R) EXTERNAL FILL PORT
Applicant
Surgitek
3037 Mt. Pleasant St.
Racine,  WI  53404
Applicant Contact BETTY A LOCK
Correspondent
Surgitek
3037 Mt. Pleasant St.
Racine,  WI  53404
Correspondent Contact BETTY A LOCK
Classification Product Code
LCJ  
Date Received07/19/1989
Decision Date 01/17/1990
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-