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 forceps, biopsy, non-electric
510(k) Number K963517
Device Name SPECTRA SCIENCE BIOPSY FORCEPS
Applicant
SPECTRASCIENCE, INC.
5909 BAKER ROAD, SUITE 580
MINNETONKA,  MN  55345
Applicant Contact BRIAN MCMAHON
Correspondent
SPECTRASCIENCE, INC.
5909 BAKER ROAD, SUITE 580
MINNETONKA,  MN  55345
Correspondent Contact BRIAN MCMAHON
Regulation Number876.1075
Classification Product Code
FCL  
Date Received09/03/1996
Decision Date 12/02/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-