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 tube, levine
510(k) Number K802007
Device Name PEDIWET=GUAZE IMPREGNATED WITH PETROL
Applicant
POLLAK (INTL.), LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
POLLAK (INTL.), LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.5980
Classification Product Code
FRQ  
Date Received08/20/1980
Decision Date 09/26/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-