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 Bag, Urine Collection, Leg, For External Use, Sterile
510(k) Number K934052
Device Name ALPINE REUSABLE LEG BAGS
Applicant
Sierra Laboratories, Inc.
3520 S. Campbell Ave.
Tucson,  AZ  85713
Applicant Contact ROBERT J KLUG
Correspondent
Sierra Laboratories, Inc.
3520 S. Campbell Ave.
Tucson,  AZ  85713
Correspondent Contact ROBERT J KLUG
Regulation Number876.5250
Classification Product Code
FAQ  
Date Received08/19/1993
Decision Date 01/07/1994
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
-
-