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 Extractor, Vacuum, Fetal
510(k) Number K020447
Device Name MITYVAC MERLIN, MODEL 10027
Applicant
Prism Enterprises, Inc.
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Prism Enterprises, Inc.
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number884.4340
Classification Product Code
HDB  
Date Received02/11/2002
Decision Date 04/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-