• 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 media, reproductive
510(k) Number K003156
Device Name BLASTASSIST SYSTEM
Applicant
MEDICULT A/S
9915 CAM. CHIRIMOLLA
SAN DIEGO,  CA  92131
Applicant Contact RONALD G LEONARDI
Correspondent
MEDICULT A/S
9915 CAM. CHIRIMOLLA
SAN DIEGO,  CA  92131
Correspondent Contact RONALD G LEONARDI
Regulation Number884.6180
Classification Product Code
MQL  
Date Received10/10/2000
Decision Date 03/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-