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 Laser, Surgical, Gynecologic
510(k) Number K875078
Device Name HERACURE LS 500
Applicant
W.C. Heraeus GmbH
Postfach 1553
D-6450 Hanau 1
West Germany,  DE
Applicant Contact WOLFRAM GORISCH
Correspondent
W.C. Heraeus GmbH
Postfach 1553
D-6450 Hanau 1
West Germany,  DE
Correspondent Contact WOLFRAM GORISCH
Regulation Number884.4550
Classification Product Code
HHR  
Date Received12/29/1987
Decision Date 02/22/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-