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 K993142
Device Name ELITE CUSTOM
Applicant
Soma Blue, Inc.
P.O. Box 1447
1025 Broad St.
Augusta,  GA  30903
Applicant Contact JOHN M MITCHELL
Correspondent
Soma Blue, Inc.
P.O. Box 1447
1025 Broad St.
Augusta,  GA  30903
Correspondent Contact JOHN M MITCHELL
Regulation Number876.5020
Classification Product Code
LKY  
Date Received09/21/1999
Decision Date 12/27/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-