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 Device, External Penile Rigidity
510(k) Number K980291
Device Name IMPOWER EXTERNAL VACUUM SYSTEM
Applicant
IMAGYN MEDICAL TECHNOLOGIES, INC.
27651 LA PAZ RD.
LAGUNA NIGUEL,  CA  92677 -3917
Applicant Contact RONALD H BERGESON
Correspondent
IMAGYN MEDICAL TECHNOLOGIES, INC.
27651 LA PAZ RD.
LAGUNA NIGUEL,  CA  92677 -3917
Correspondent Contact RONALD H BERGESON
Regulation Number876.5020
Classification Product Code
LKY  
Date Received01/26/1998
Decision Date 03/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-