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 Apparatus, Exhaust, Surgical
510(k) Number K983298
Device Name BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF
Applicant
BUFFALO FILTER CO., INC.
6000 N. BAILEY AVE, SUITE 9
BUFFALO,  NY  14226
Applicant Contact CLINTON R HOLLAND JR.
Correspondent
BUFFALO FILTER CO., INC.
6000 N. BAILEY AVE, SUITE 9
BUFFALO,  NY  14226
Correspondent Contact CLINTON R HOLLAND JR.
Regulation Number878.5070
Classification Product Code
FYD  
Date Received09/21/1998
Decision Date 08/16/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-