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 K871875
Device Name MODEL 5050 SURGILASER FOR OB-GYN USE
Applicant
LASERMATIC, INC.
P.O. BOX 7848
DALLAS,  TX  75209
Applicant Contact DONALD F HULTS
Correspondent
LASERMATIC, INC.
P.O. BOX 7848
DALLAS,  TX  75209
Correspondent Contact DONALD F HULTS
Regulation Number884.4550
Classification Product Code
HHR  
Date Received05/14/1987
Decision Date 08/22/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-