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 K920205
Device Name OTT INSUFFLATION FILTER TUBING
Applicant
GEORGIA BIOMEDICAL RESEARCH GROUP, INC.
250 CHARTER LANE, STE. 101
MACON,  GA  31210
Applicant Contact DOUGLAS E OTT
Correspondent
GEORGIA BIOMEDICAL RESEARCH GROUP, INC.
250 CHARTER LANE, STE. 101
MACON,  GA  31210
Correspondent Contact DOUGLAS E OTT
Regulation Number884.1730
Classification Product Code
HIF  
Date Received01/16/1992
Decision Date 10/25/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-