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 Unit, Cautery, Thermal, Ac-Powered
510(k) Number K002341
Device Name THERMAL CAUTERY UNIT, MODEL 150
Applicant
Geiger Medical Technologies, Inc.
24040 Camino Del Avion, A-195
Monarch Beach,  CA  92629
Applicant Contact JOHN BOTTJER
Correspondent
Geiger Medical Technologies, Inc.
24040 Camino Del Avion, A-195
Monarch Beach,  CA  92629
Correspondent Contact JOHN BOTTJER
Regulation Number886.4115
Classification Product Code
HQO  
Date Received08/01/2000
Decision Date 10/23/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-