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, Urological
510(k) Number K875383
Device Name LAKE CATHETER CARE KITS (MODIFICATION)
Applicant
Lake Medical Products, Inc.
1145 Moog Dr.
St. Louis,  MO  63146
Applicant Contact ELI SCHACHET
Correspondent
Lake Medical Products, Inc.
1145 Moog Dr.
St. Louis,  MO  63146
Correspondent Contact ELI SCHACHET
Regulation Number876.5130
Classification Product Code
KOD  
Date Received12/15/1987
Decision Date 03/09/1988
Decision Substantially Equivalent - With Drug (SESD)
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
-
-