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 electrocautery, gynecologic (and accessories)
510(k) Number K961460
Device Name LWEET CONE BIOPSY INSTRUMENT
Applicant
APPLE MEDICAL CORP.
23 WEILSEWITZ RD.
RINGOES,  NJ  08551
Applicant Contact RANDOLPH L COOKE
Correspondent
APPLE MEDICAL CORP.
23 WEILSEWITZ RD.
RINGOES,  NJ  08551
Correspondent Contact RANDOLPH L COOKE
Regulation Number884.4120
Classification Product Code
HGI  
Date Received04/16/1996
Decision Date 11/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-