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 Mesh, Surgical
510(k) Number K992537
Device Name PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED
Applicant
Bio-Vascular, Inc.
2575 University Ave.
St. Paul,  MN  55114 -1024
Applicant Contact MARY KAY KESSINGER SOBCINSKI
Correspondent
Bio-Vascular, Inc.
2575 University Ave.
St. Paul,  MN  55114 -1024
Correspondent Contact MARY KAY KESSINGER SOBCINSKI
Regulation Number878.3300
Classification Product Code
FTM  
Date Received07/29/1999
Decision Date 02/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-