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 apparatus, exhaust, surgical
510(k) Number K001082
Device Name STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100
Applicant
STACKHOUSE, INC.
1100 BIRD CENTER DR.
PALM SPRINGS,  CA  92262
Applicant Contact TOM GUTIERREZ
Correspondent
STACKHOUSE, INC.
1100 BIRD CENTER DR.
PALM SPRINGS,  CA  92262
Correspondent Contact TOM GUTIERREZ
Regulation Number878.5070
Classification Product Code
FYD  
Date Received04/04/2000
Decision Date 06/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-