• 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 needle, aspiration and injection, disposable
510(k) Number K880377
Device Name NOVO VIVO MODEL #17140 AND #17135
Applicant
GENESIS INDUSTRIES, INC.
214 MCKAY AVE.
SPRING VALLEY,  WI  54767
Applicant Contact ANDERSON, DVM
Correspondent
GENESIS INDUSTRIES, INC.
214 MCKAY AVE.
SPRING VALLEY,  WI  54767
Correspondent Contact ANDERSON, DVM
Regulation Number878.4800
Classification Product Code
GAA  
Date Received01/27/1988
Decision Date 04/04/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-