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 Punch, Surgical
510(k) Number K896303
Device Name BIOPSY PUNCH
Applicant
Premier Medical
1710 Romano Dr.
P.O. Box 111
Norristown,  PA  19404
Applicant Contact ROBERT E REGAN
Correspondent
Premier Medical
1710 Romano Dr.
P.O. Box 111
Norristown,  PA  19404
Correspondent Contact ROBERT E REGAN
Regulation Number878.4800
Classification Product Code
LRY  
Date Received10/30/1989
Decision Date 02/13/1990
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
-
-