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 Perineometer
510(k) Number K860552
Device Name PERITONE DISPOSAL SHEATH - RUBBER AND VINYL
Applicant
Laurie Ann Kaiser, Ph.D.
75-04 - 249th St.
Bellerose,  NY  11426
Applicant Contact ANN KAISER
Correspondent
Laurie Ann Kaiser, Ph.D.
75-04 - 249th St.
Bellerose,  NY  11426
Correspondent Contact ANN KAISER
Regulation Number884.1425
Classification Product Code
HIR  
Date Received02/14/1986
Decision Date 04/17/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-