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 K896838
Device Name BISTAT ELECTROSURGICAL UNIT 60-5400-001
Applicant
Aspen Laboratories, Inc.
8089 S. Lincoln St.
Littleton,  CO  80122
Applicant Contact JANE JOHNSON
Correspondent
Aspen Laboratories, Inc.
8089 S. Lincoln St.
Littleton,  CO  80122
Correspondent Contact JANE JOHNSON
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/05/1989
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
-
-