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 Dilator, Urethral
510(k) Number K873295
Device Name PROSTATIC URETHRO. BALLOON DILATATION CATHETER
Applicant
Medi-Tech, Inc.
480 Plesant St.
P.O. Box 7407
Watertown,  MA  02272
Applicant Contact ALBERT P SEPRINSKI
Correspondent
Medi-Tech, Inc.
480 Plesant St.
P.O. Box 7407
Watertown,  MA  02272
Correspondent Contact ALBERT P SEPRINSKI
Regulation Number876.5520
Classification Product Code
KOE  
Date Received08/17/1987
Decision Date 07/31/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-