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, Hysteroscopic
510(k) Number K933873
Device Name CONCEPT UNIVERSAL PUMP SYSTEM
Applicant
Linvatec Corp.
11311 Concept Blvd.
Largo,  FL  33773
Applicant Contact MARTHA C MILLER
Correspondent
Linvatec Corp.
11311 Concept Blvd.
Largo,  FL  33773
Correspondent Contact MARTHA C MILLER
Regulation Number884.1700
Classification Product Code
HIG  
Subsequent Product Code
BTA  
Date Received08/09/1993
Decision Date 12/29/1994
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
-
-