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 Catheter, Balloon Type
510(k) Number K861877
Device Name BYRON WORD BARTHOLIAN GLAND CATHETER
Applicant
BYRON MEDICAL
3280 E. HEMISPHERE LOOP
SUITE 100
TUCSON,  AZ  85706
Applicant Contact FRED CHAPEL
Correspondent
BYRON MEDICAL
3280 E. HEMISPHERE LOOP
SUITE 100
TUCSON,  AZ  85706
Correspondent Contact FRED CHAPEL
Regulation Number878.4200
Classification Product Code
GBA  
Date Received05/15/1986
Decision Date 05/30/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-