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, Carbon-Dioxide, Uterotubal (And Accessories)
510(k) Number K903209
Device Name MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER
Applicant
ADLER INSTRUMENT CO.
6191 ATLANTIC BLVD.
NORCROSS,  GA  30071
Applicant Contact NORMAN BLACK
Correspondent
ADLER INSTRUMENT CO.
6191 ATLANTIC BLVD.
NORCROSS,  GA  30071
Correspondent Contact NORMAN BLACK
Regulation Number884.1300
Classification Product Code
HES  
Date Received07/20/1990
Decision Date 12/21/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-