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, Incontinence, Urosheath Type, Sterile
510(k) Number K962384
Device Name COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER
Applicant
SIERRA LABORATORIES, INC.
3520 SOUTH CAMPBELL AVE.
TUCSON,  AZ  85713
Applicant Contact ANNA PEREZ
Correspondent
SIERRA LABORATORIES, INC.
3520 SOUTH CAMPBELL AVE.
TUCSON,  AZ  85713
Correspondent Contact ANNA PEREZ
Regulation Number876.5250
Classification Product Code
EXJ  
Subsequent Product Code
EYT  
Date Received06/20/1996
Decision Date 07/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-