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 Douche Apparatus, Vaginal, Therapeutic
510(k) Number K781207
Device Name DOUCHE KIT, SOMETHING PERSONAL
Applicant
Chatten Drug & Chemical Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Chatten Drug & Chemical Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number884.5900
Classification Product Code
HED  
Date Received07/14/1978
Decision Date 08/10/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-