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 Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K896055
Device Name ERBOTOM ACC 450
Applicant
Erbe Electromedizin GmbH
9025 E. Kenyon
Denver,  CO  80237
Applicant Contact ROBERT RICHARDS
Correspondent
Erbe Electromedizin GmbH
9025 E. Kenyon
Denver,  CO  80237
Correspondent Contact ROBERT RICHARDS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/18/1989
Decision Date 02/13/1990
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
-
-