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
510(k) Number K863604
Device Name DISPOSABLE BLADES FOR ARTHROSCOPIC SURGICAL DEVICE
Applicant
American Edwards Laboratories
P.O. Box 11150
17221 Red Hill Ave.(Irvine)
Santa Ana,  CA  92711
Applicant Contact DIECK, PHD
Correspondent
American Edwards Laboratories
P.O. Box 11150
17221 Red Hill Ave.(Irvine)
Santa Ana,  CA  92711
Correspondent Contact DIECK, PHD
Date Received09/16/1986
Decision Date 10/03/1986
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
-
-