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 Needle, Spinal, Short Term
510(k) Number K942442
Device Name ACUFEX T-FIX DELIVERY SYSTEM
Applicant
ACUFEX MICROSURGICAL, INC.
130 FORBES BLVD.
MANSFIELD,  MA  02048
Applicant Contact FREDERICK TOBIA
Correspondent
ACUFEX MICROSURGICAL, INC.
130 FORBES BLVD.
MANSFIELD,  MA  02048
Correspondent Contact FREDERICK TOBIA
Regulation Number868.5150
Classification Product Code
MIA  
Date Received05/23/1994
Decision Date 12/05/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-