• 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 | Inspections
 


New Search Back To Search Results
Device Classification Name arthroscope
510(k) Number K931621
Device Name ACUFEX PRO-PAC AND ISO-PAC
Original Applicant
ACUFEX MICROSURGICAL, INC.
130 forbes blvd.
mansfield,  MA  02048
Original Contact frederick tobia
Regulation Number888.1100
Classification Product Code
HRX  
Date Received04/02/1993
Decision Date 01/21/1994
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-