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 K875137
Device Name LAPAROFLATOR 3000, STANDARD AND ELECTRONIC
Applicant
F.M. WIEST USA, INC.
1301 N. KINGS HIGHWAY
CHERRY HILL,  NJ  08034
Applicant Contact WAYNE W DISANZA
Correspondent
F.M. WIEST USA, INC.
1301 N. KINGS HIGHWAY
CHERRY HILL,  NJ  08034
Correspondent Contact WAYNE W DISANZA
Regulation Number884.1300
Classification Product Code
HES  
Date Received12/15/1987
Decision Date 03/02/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-