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 Laparoscope, Gynecologic (And Accessories)
510(k) Number K910209
Device Name LAPAROSCOPIC IRRIGATOR/ASPIRATOR
Applicant
SOLOS MFG.
820 SWAN DR.
MUKWONAGO,  WI  53149
Applicant Contact RONALD HUENEKE
Correspondent
SOLOS MFG.
820 SWAN DR.
MUKWONAGO,  WI  53149
Correspondent Contact RONALD HUENEKE
Regulation Number884.1720
Classification Product Code
HET  
Date Received01/15/1991
Decision Date 04/29/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-