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 Powered Laser Surgical Instrument
510(k) Number K893529
Device Name COMBOLASER MODEL 5050
Applicant
Lasermatic, Inc.
Medical Device Consultants Inc
45 W. Streert, Suite 2
Attleboro,  MA  02703
Applicant Contact TOBY FULLER
Correspondent
Lasermatic, Inc.
Medical Device Consultants Inc
45 W. Streert, Suite 2
Attleboro,  MA  02703
Correspondent Contact TOBY FULLER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/08/1989
Decision Date 06/08/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-