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 Prosthesis, Penile
510(k) Number K850019
Device Name OMNI PHASE PENILE PROSTHESIS
Applicant
DACOMED CORP.
1701 E. 79TH ST., STE. 17
MINNEAPOLIS,  MN  55425
Applicant Contact FRANK B FREEDMAN
Correspondent
DACOMED CORP.
1701 E. 79TH ST., STE. 17
MINNEAPOLIS,  MN  55425
Correspondent Contact FRANK B FREEDMAN
Regulation Number876.3630
Classification Product Code
FAE  
Date Received01/03/1985
Decision Date 04/09/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-