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 device
510(k) Number K931215
Device Name HAND-TROL S
Applicant
ASPEN LABS
14603 E. FREMONT AVE.
ENGLEWOOD,  CO  80112
Applicant Contact JANE JOHNSON
Correspondent
ASPEN LABS
14603 E. FREMONT AVE.
ENGLEWOOD,  CO  80112
Correspondent Contact JANE JOHNSON
Regulation Number878.4400
Classification Product Code
DWG  
Date Received03/10/1993
Decision Date 03/28/1994
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
-
-