• 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 Apparatus, Suction, Single Patient Use, Portable, Nonpowered
510(k) Number K881036
Device Name HEMO SUC NUMBER HS100-HS205
Applicant
INSTRUMENTAL MEDICO CROQUEVIELLE S.A.
FOR EMBASSADOR
MAGALLANES 062, CASILLA 2158
SANTIAGO, CHILE,  CL
Applicant Contact CROQUEVIELLE I.
Correspondent
INSTRUMENTAL MEDICO CROQUEVIELLE S.A.
FOR EMBASSADOR
MAGALLANES 062, CASILLA 2158
SANTIAGO, CHILE,  CL
Correspondent Contact CROQUEVIELLE I.
Regulation Number878.4680
Classification Product Code
GCY  
Date Received03/10/1988
Decision Date 06/20/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-