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 Mask, Surgical
510(k) Number K011789
Device Name PROCEDURE MASKS: PM4-301 AND PM4-304
Applicant
Primeline Medical Products, Inc.
10707 100th Ave., Suite 300
Edmonton, Alberta,  CA T5J 3M1
Applicant Contact KATHERINE CO
Correspondent
Primeline Medical Products, Inc.
10707 100th Ave., Suite 300
Edmonton, Alberta,  CA T5J 3M1
Correspondent Contact KATHERINE CO
Regulation Number878.4040
Classification Product Code
FXX  
Date Received06/08/2001
Decision Date 06/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-