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 K925691
Device Name INSUFFLATION TUBING
Applicant
MECTRA LABS, INC.
HIGHWAY 231 SOUTH,
2 QUALITY WAY
BLOOMFIELD,  IN  47424
Applicant Contact THOMAS P CLEMENT
Correspondent
MECTRA LABS, INC.
HIGHWAY 231 SOUTH,
2 QUALITY WAY
BLOOMFIELD,  IN  47424
Correspondent Contact THOMAS P CLEMENT
Regulation Number884.1730
Classification Product Code
HIF  
Subsequent Product Code
GCJ  
Date Received11/12/1992
Decision Date 09/23/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-