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 Apparatus, Autotransfusion
510(k) Number K913177
Device Name SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM
Applicant
Solco Basle, Inc.
72 Sharp St.
Hingham Corporate Ctr.
Hingham,  MA  02043
Applicant Contact ROBERT W CUNNINGHAM
Correspondent
Solco Basle, Inc.
72 Sharp St.
Hingham Corporate Ctr.
Hingham,  MA  02043
Correspondent Contact ROBERT W CUNNINGHAM
Regulation Number868.5830
Classification Product Code
CAC  
Date Received07/17/1991
Decision Date 02/25/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-