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 cap, surgical
510(k) Number K953879
Device Name SURGEON'S CAP
Applicant
AMERICAN THRESHOLD INDUSTRIES, INC.
240 SARDIS RD.
P.O. BOX 1209
ENKA,  NC  28728
Applicant Contact GREGORY B SCOTT
Correspondent
AMERICAN THRESHOLD INDUSTRIES, INC.
240 SARDIS RD.
P.O. BOX 1209
ENKA,  NC  28728
Correspondent Contact GREGORY B SCOTT
Regulation Number878.4040
Classification Product Code
FYF  
Date Received08/16/1995
Decision Date 01/05/1996
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
-
-