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 Tourniquet, Pneumatic
510(k) Number K954201
Device Name BUONAFEDE PNEUMATIC SLEEVE
Applicant
Promedic, Inc.
67920 Klinger Lake Rd.
Sturgis,  MI  49091
Applicant Contact PAUL E DRYDEN
Correspondent
Promedic, Inc.
67920 Klinger Lake Rd.
Sturgis,  MI  49091
Correspondent Contact PAUL E DRYDEN
Regulation Number878.5910
Classification Product Code
KCY  
Date Received09/06/1995
Decision Date 11/09/1995
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
Predetermined Change
Control Plan Authorized		 No
-
-