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 Gauze/Sponge, Internal
510(k) Number K905068
Device Name PTI INTRA-ART (TM) PICK-UP WICKS
Applicant
Pioneering Technologies, Inc.
3900 Youngfield St.
Wheat Ridge,  CO  80033
Applicant Contact WRIGHT
Correspondent
Pioneering Technologies, Inc.
3900 Youngfield St.
Wheat Ridge,  CO  80033
Correspondent Contact WRIGHT
Classification Product Code
EFQ  
Date Received11/09/1990
Decision Date 12/31/1991
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-