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 Arthroscope
510(k) Number K884314
Device Name LEONARD MEDICAL 1.7MM ARTHROSCOPE
Applicant
Leonard Medical, Inc.
1464 Holcomb Rd.
Huntingdon Valley,  PA  19006
Applicant Contact LEONARD J BONNELL
Correspondent
Leonard Medical, Inc.
1464 Holcomb Rd.
Huntingdon Valley,  PA  19006
Correspondent Contact LEONARD J BONNELL
Regulation Number888.1100
Classification Product Code
HRX  
Date Received10/13/1988
Decision Date 03/13/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-