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, Nonpneumatic
510(k) Number K864897
Device Name DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335
Applicant
Dale Medical Products, Inc.
7 Cross St.
P.O. Box 1556
Plainville,  MA  02762
Applicant Contact DANIEL W MCELANEY
Correspondent
Dale Medical Products, Inc.
7 Cross St.
P.O. Box 1556
Plainville,  MA  02762
Correspondent Contact DANIEL W MCELANEY
Regulation Number878.5900
Classification Product Code
GAX  
Date Received12/15/1986
Decision Date 01/12/1987
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
-
-