• 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 Balloon, Epistaxis
510(k) Number K920358
Device Name ULTRACELL NASAL PACKING
Applicant
ULTRACELL MEDICAL TECHNOLOGIES, INC.
P.O. BOX 326
NORTH STONINGTON,  CT  06359
Applicant Contact GEORGE P KORTEWEG
Correspondent
ULTRACELL MEDICAL TECHNOLOGIES, INC.
P.O. BOX 326
NORTH STONINGTON,  CT  06359
Correspondent Contact GEORGE P KORTEWEG
Regulation Number874.4100
Classification Product Code
EMX  
Date Received01/27/1992
Decision Date 11/30/1992
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
Recalls CDRH Recalls
-
-