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 Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K972781
Device Name OT-1
Applicant
Prism Therapeutics, LLC
11504 Riveredge Rd.
Doswell,  VA  23047
Applicant Contact MARK LICATA
Correspondent
Prism Therapeutics, LLC
11504 Riveredge Rd.
Doswell,  VA  23047
Correspondent Contact MARK LICATA
Regulation Number876.1500
Classification Product Code
FED  
Date Received07/25/1997
Decision Date 09/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-