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 Set, Anesthesia, Paracervical
510(k) Number K910253
Device Name LEEP REDIKIT
Applicant
CooperSurgical, Inc.
C/O Charles I. Rose & Co, Inc.
1963 Rock St., Suite #17
Mountain View,  CA  94043
Applicant Contact CHARLES L ROSE
Correspondent
CooperSurgical, Inc.
C/O Charles I. Rose & Co, Inc.
1963 Rock St., Suite #17
Mountain View,  CA  94043
Correspondent Contact CHARLES L ROSE
Regulation Number884.5100
Classification Product Code
HEE  
Date Received01/22/1991
Decision Date 04/18/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-