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 Media, Reproductive
510(k) Number K213293
Device Name V-HEPES PLUS
Applicant
Vitromed Langenfeld
Raoffeosemstr 15a
Langenfeld,  DE 40764
Applicant Contact Greg Holland
Correspondent
Regulatory Specialists, Inc.
3722 Ave. Sausalito
Irvine,  CA  92606
Correspondent Contact Greg Holland
Regulation Number884.6180
Classification Product Code
MQL  
Date Received10/01/2021
Decision Date 09/14/2022
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
-
-