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 needle, assisted reproduction
510(k) Number K003056
Device Name OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218
Applicant
LABOTECT LABOR-TECHNIK GOTTINGEN
WILLI-EICHLER-STR. 25
GOTTINGEN,  DE D-37079
Applicant Contact ANGELIKA ALBRECHT
Correspondent
LABOTECT LABOR-TECHNIK GOTTINGEN
WILLI-EICHLER-STR. 25
GOTTINGEN,  DE D-37079
Correspondent Contact ANGELIKA ALBRECHT
Regulation Number884.6100
Classification Product Code
MQE  
Date Received10/01/2000
Decision Date 12/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-