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, Biopsy
510(k) Number K862562
Device Name PUNCH BIOPSY KIT
Applicant
Clinipad Corp.
66 High St.
P.O. Box 387
Guilford,  CT  06437
Applicant Contact SIDNEY FINKELSTEIN
Correspondent
Clinipad Corp.
66 High St.
P.O. Box 387
Guilford,  CT  06437
Correspondent Contact SIDNEY FINKELSTEIN
Regulation Number876.1075
Classification Product Code
KNW  
Date Received07/03/1986
Decision Date 10/07/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-