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 Cannula, Sinus
510(k) Number K922145
Device Name SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS
Applicant
Atos Medical AB
9229 Cranford Dr.
Potomac,  MD  20854
Applicant Contact R. J SLOMOFF
Correspondent
Atos Medical AB
9229 Cranford Dr.
Potomac,  MD  20854
Correspondent Contact R. J SLOMOFF
Regulation Number878.4800
Classification Product Code
KAM  
Date Received05/07/1992
Decision Date 01/21/1993
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
Predetermined Change
Control Plan Authorized		 No
-
-