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 marker, radiographic, implantable
510(k) Number K121113
Device Name BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER
Applicant
BIOPSY SCIENCES, LLC
5582 CHALON RD.
YORBA LINDA,  FL  33760
Applicant Contact SHARON ROCKWELL
Correspondent
BIOPSY SCIENCES, LLC
5582 CHALON RD.
YORBA LINDA,  FL  33760
Correspondent Contact SHARON ROCKWELL
Regulation Number878.4300
Classification Product Code
NEU  
Date Received04/12/2012
Decision Date 07/12/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-