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 Cystoscope And Accessories, Flexible/Rigid
510(k) Number K902274
Device Name CUSTOMED CYSTO PACK I
Applicant
Customed, Inc.
Box 7699
Carolina
Puerto Rico, 
Applicant Contact FELIX B SANTOS
Correspondent
Customed, Inc.
Box 7699
Carolina
Puerto Rico, 
Correspondent Contact FELIX B SANTOS
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received05/21/1990
Decision Date 09/20/1990
Decision Substantially Equivalent - Kit (SESK)
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
Recalls CDRH Recalls
-
-