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 Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
510(k) Number K954989
Device Name DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES
Applicant
SMITH & NEPHEW DYONICS, INC.
160 DASCOMB RD.
ANDOVER,  MA  01810
Applicant Contact DEBORAH J CONNORS
Correspondent
SMITH & NEPHEW DYONICS, INC.
160 DASCOMB RD.
ANDOVER,  MA  01810
Correspondent Contact DEBORAH J CONNORS
Regulation Number874.4250
Classification Product Code
ERL  
Date Received10/31/1995
Decision Date 11/27/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-