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 K893417
Device Name SURGIFRESH SUB-MICRON MASK NO. 901008-000
Applicant
Texas Medical Products, Inc.
2828 N. Crescent Ridge Dr.
The Woodlands,  TX  77381
Applicant Contact ROGER MOGILL
Correspondent
Texas Medical Products, Inc.
2828 N. Crescent Ridge Dr.
The Woodlands,  TX  77381
Correspondent Contact ROGER MOGILL
Regulation Number878.4040
Classification Product Code
FXX  
Date Received05/02/1989
Decision Date 06/22/1989
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
-
-