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 bone grafting material, synthetic
510(k) Number K955096
Device Name CAPSET CALCIUM SULFATE BONE GRAFT PLASTER
Applicant
LIFECORE BIOMEDICAL, INC.
3515 LYMAN BLVD.
CHASKA,  MN  55318
Applicant Contact LYNN CUPERUS
Correspondent
LIFECORE BIOMEDICAL, INC.
3515 LYMAN BLVD.
CHASKA,  MN  55318
Correspondent Contact LYNN CUPERUS
Regulation Number872.3930
Classification Product Code
LYC  
Date Received11/07/1995
Decision Date 01/23/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-