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 Curette, Suction, Endometrial (And Accessories)
510(k) Number K001545
Device Name PIPET CURET
Applicant
Milex Products, Inc.
4311 N. Normandy Ave.
Chicago,  IL  60634
Applicant Contact CARA FURLONG
Correspondent
Milex Products, Inc.
4311 N. Normandy Ave.
Chicago,  IL  60634
Correspondent Contact CARA FURLONG
Regulation Number884.1175
Classification Product Code
HHK  
Date Received05/18/2000
Decision Date 06/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-