• 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 needle, fistula
510(k) Number K854951
Device Name PLUME Y SET
Applicant
HOSPAL MEDICAL CORP.
25 KIMBERLY RD.
P.O. BOX 857
EAST BRUNSWICK,  NJ  08816
Applicant Contact DOUGLAS L VLCHEK
Correspondent
HOSPAL MEDICAL CORP.
25 KIMBERLY RD.
P.O. BOX 857
EAST BRUNSWICK,  NJ  08816
Correspondent Contact DOUGLAS L VLCHEK
Regulation Number876.5540
Classification Product Code
FIE  
Date Received12/10/1985
Decision Date 01/08/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-