• 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 Uroflowmeter
510(k) Number K951442
Device Name FLOLAB
Applicant
SYNECTICS MEDICAL, INC.
RENSTIENAS GATA 12, 5TR.
S-116 28 STOCKHOLM,  SE S-11628
Applicant Contact ANNA PETTERSSON
Correspondent
SYNECTICS MEDICAL, INC.
RENSTIENAS GATA 12, 5TR.
S-116 28 STOCKHOLM,  SE S-11628
Correspondent Contact ANNA PETTERSSON
Regulation Number876.1800
Classification Product Code
EXY  
Date Received03/29/1995
Decision Date 08/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-