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 Kit, Surgical Instrument, Disposable
510(k) Number K924958
Device Name BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY
Applicant
Medical Insights, Inc.
193 Whitehall Ave.
Mystic,  CT  06355
Applicant Contact CARL G BARSANTI
Correspondent
Medical Insights, Inc.
193 Whitehall Ave.
Mystic,  CT  06355
Correspondent Contact CARL G BARSANTI
Regulation Number878.4800
Classification Product Code
KDD  
Date Received09/30/1992
Decision Date 06/07/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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
-
-