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 K000730
Device Name IMPOAID
Applicant
Impoaid, Inc.
P.O. Box 560
Stillwater,  MN  55082
Applicant Contact ELAIN DUNCAN
Correspondent
Impoaid, Inc.
P.O. Box 560
Stillwater,  MN  55082
Correspondent Contact ELAIN DUNCAN
Regulation Number876.5020
Classification Product Code
LKY  
Date Received03/06/2000
Decision Date 10/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-