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, Uterine
510(k) Number K980096
Device Name OAC (OPTICAL ASPIRATING CURETTE)
Applicant
Imagyn Medical Technologies, Inc.
27651 La Paz Rd.
Laguna Niguel,  CA  92677
Applicant Contact RONALD H BERGESON
Correspondent
Imagyn Medical Technologies, Inc.
27651 La Paz Rd.
Laguna Niguel,  CA  92677
Correspondent Contact RONALD H BERGESON
Regulation Number884.4530
Classification Product Code
HCY  
Subsequent Product Code
HIH  
Date Received01/09/1998
Decision Date 05/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-