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 Insufflator, Laparoscopic
510(k) Number K021247
Device Name PNEUMOPERITONEUM INSUFFLATION NEEDLE
Applicant
MECTRA LABS, INC.
P.O. BOX 350
BLOOMFIELD,  IN  47424
Applicant Contact CHARLES E ALLGOOD
Correspondent
MECTRA LABS, INC.
P.O. BOX 350
BLOOMFIELD,  IN  47424
Correspondent Contact CHARLES E ALLGOOD
Regulation Number884.1730
Classification Product Code
HIF  
Date Received04/19/2002
Decision Date 11/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-