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 Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K954264
Device Name ACI SINGLE LUMEN BIOPSY NEEDLE
Applicant
Advanced Cytometrix, Inc.
995 Benecia Ave.
Sunnyvale,  CA  94086
Applicant Contact DEEPAK GHANDI
Correspondent
Advanced Cytometrix, Inc.
995 Benecia Ave.
Sunnyvale,  CA  94086
Correspondent Contact DEEPAK GHANDI
Regulation Number878.4780
Classification Product Code
BTA  
Date Received09/12/1995
Decision Date 11/29/1995
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
-
-