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 Accessories, Cleaning, For Endoscope
510(k) Number K923687
Device Name ONE DIRECTIONAL CLEANING BRUSH
Applicant
Endoscopy Support Services, Inc.
75 Haviland Dr.
Paterson,  NY  12563
Applicant Contact ROBERT SAVITT
Correspondent
Endoscopy Support Services, Inc.
75 Haviland Dr.
Paterson,  NY  12563
Correspondent Contact ROBERT SAVITT
Regulation Number876.1500
Classification Product Code
FEB  
Date Received07/23/1992
Decision Date 09/23/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-