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 tube, drainage, suprapubic
510(k) Number K864770
Device Name SUCTION TUBE
Applicant
NEW ENGLAND SURGICAL INSTRUMENT CORP.
P.O. BOX 35
83 EAST WATER STREET
ROCKLAND,  MA  02370
Applicant Contact RICHARD M BEANE
Correspondent
NEW ENGLAND SURGICAL INSTRUMENT CORP.
P.O. BOX 35
83 EAST WATER STREET
ROCKLAND,  MA  02370
Correspondent Contact RICHARD M BEANE
Regulation Number876.5090
Classification Product Code
FFA  
Date Received12/05/1986
Decision Date 02/24/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-