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 pump, portable, aspiration (manual or powered)
510(k) Number K853917
Device Name EGNELL COMPACT SUCTION PUMP
Applicant
EGNELL, INC.
333 W. WACKER DR.
SUITE 1900
CHICAGO,  IL  60606
Applicant Contact JOHN F LEMKER
Correspondent
EGNELL, INC.
333 W. WACKER DR.
SUITE 1900
CHICAGO,  IL  60606
Correspondent Contact JOHN F LEMKER
Regulation Number878.4780
Classification Product Code
BTA  
Date Received09/23/1985
Decision Date 11/25/1985
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-