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 Balloon, Epistaxis
510(k) Number K963856
Device Name RAND NASAL PACKING
Applicant
Rand Scientific Corp.
4135 Northgate Blvd. Suite 9
Sacramento,  CA  95834
Applicant Contact DUANE TRACY
Correspondent
Rand Scientific Corp.
4135 Northgate Blvd. Suite 9
Sacramento,  CA  95834
Correspondent Contact DUANE TRACY
Regulation Number874.4100
Classification Product Code
EMX  
Date Received09/25/1996
Decision Date 10/18/1996
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
Predetermined Change
Control Plan Authorized		 No
-
-