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 retractor
510(k) Number K050256
Device Name APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR
Applicant
APPLE MEDICAL CORP.
75 FEDERAL STREET, 9TH FL
BOSTON,  MA  02110
Applicant Contact JAMES DELANEY
Correspondent
APPLE MEDICAL CORP.
75 FEDERAL STREET, 9TH FL
BOSTON,  MA  02110
Correspondent Contact JAMES DELANEY
Regulation Number878.4800
Classification Product Code
GAD  
Date Received02/03/2005
Decision Date 04/26/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-