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 marker, skin
510(k) Number K840820
Device Name SECURLINE SURGICAL SKIN MARKER 1000
Applicant
PRECISION DYNAMICS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PRECISION DYNAMICS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4660
Classification Product Code
FZZ  
Date Received02/24/1984
Decision Date 04/25/1984
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
-
-