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 Cap, Surgical
510(k) Number K851558
Device Name SURGICAL CAP CALOT
Applicant
ROSEBURG SA
1054 31ST STREET, N.W.
SUITE 120 CANAL SQUARE
WASHINGTON,  DC  20007
Applicant Contact CHAMBORD
Correspondent
ROSEBURG SA
1054 31ST STREET, N.W.
SUITE 120 CANAL SQUARE
WASHINGTON,  DC  20007
Correspondent Contact CHAMBORD
Regulation Number878.4040
Classification Product Code
FYF  
Date Received04/16/1985
Decision Date 04/30/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-