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 scalpel, one-piece
510(k) Number K904505
Device Name CCI CORNEAL SCARIFIER
Applicant
BUCKMAN CO., INC.
1000 BURNETT AVE.
SUITE 450
CONCORD,  CA  94520
Applicant Contact DAVID SCHLERF
Correspondent
BUCKMAN CO., INC.
1000 BURNETT AVE.
SUITE 450
CONCORD,  CA  94520
Correspondent Contact DAVID SCHLERF
Regulation Number878.4800
Classification Product Code
GDX  
Date Received10/02/1990
Decision Date 04/23/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-