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 Instrument, Ligature Passing And Knot Tying
510(k) Number K931379
Device Name MICROVASIVE INSURG LAPTIE SUTURE LIGATOR
Applicant
Boston Scientific Corp
2710 Orchard Pkwy.
San Jose,  CA  95134
Applicant Contact STEPHEN M PAGE
Correspondent
Boston Scientific Corp
2710 Orchard Pkwy.
San Jose,  CA  95134
Correspondent Contact STEPHEN M PAGE
Regulation Number878.4800
Classification Product Code
HCF  
Subsequent Product Code
GCJ  
Date Received03/18/1993
Decision Date 07/13/1993
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
Predetermined Change
Control Plan Authorized		 No
-
-