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 Needle, Aspiration And Injection, Disposable
510(k) Number K925621
Device Name IRRIGATION/ASPIRATION TUBING SET
Applicant
Kirwan Surgical Products, Inc.
83 E. Water St.
P.O. Box 545
Rockland,  MA  02370
Applicant Contact DANA A OLIVER
Correspondent
Kirwan Surgical Products, Inc.
83 E. Water St.
P.O. Box 545
Rockland,  MA  02370
Correspondent Contact DANA A OLIVER
Regulation Number878.4800
Classification Product Code
GAA  
Date Received11/06/1992
Decision Date 05/07/1993
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
-
-