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 K932137
Device Name FLUIDSHIELD SURGICAL/PROCEDURE MASK/M. WITH VISOR
Applicant
Tecnol Medical Products, Inc.
7201 Industrial Park Blvd.
Fort Worth,  TX  76180
Applicant Contact LEONA M HAMMEL
Correspondent
Tecnol Medical Products, Inc.
7201 Industrial Park Blvd.
Fort Worth,  TX  76180
Correspondent Contact LEONA M HAMMEL
Regulation Number878.4040
Classification Product Code
FXX  
Date Received04/27/1993
Decision Date 04/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-