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 Instrument, Surgical, Disposable
510(k) Number K854897
Device Name MAX-I-GRASP
Applicant
EURO-MED INTL.
ADVANCED BIOSEARCH ASSOCIATES
3880 BLACKHAWK ROAD
DANVILLE,  CA  94526
Applicant Contact DONALD HOLSTEN
Correspondent
EURO-MED INTL.
ADVANCED BIOSEARCH ASSOCIATES
3880 BLACKHAWK ROAD
DANVILLE,  CA  94526
Correspondent Contact DONALD HOLSTEN
Regulation Number878.4800
Classification Product Code
KDC  
Date Received12/06/1985
Decision Date 05/02/1986
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
-
-