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 Lavage, Jet
510(k) Number K012464
Device Name HELIX HYDRO-JET
Applicant
ANDREAS PEIN MEDIZINTECHNIK GMBH
13605 WEST 7TH AVE.
GOLDEN,  CO  80401 -4604
Applicant Contact ROBERT N CLARK
Correspondent
ANDREAS PEIN MEDIZINTECHNIK GMBH
13605 WEST 7TH AVE.
GOLDEN,  CO  80401 -4604
Correspondent Contact ROBERT N CLARK
Regulation Number880.5475
Classification Product Code
FQH  
Date Received08/01/2001
Decision Date 10/10/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-