• 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 Tray, Surgical
510(k) Number K873290
Device Name LACERATION AND INSTRUMENT TRAYS
Applicant
Advantage Medical Systems, Inc.
905 Sheehy Dr.
Horsham,  PA  19044
Applicant Contact JOEL A MARCUS
Correspondent
Advantage Medical Systems, Inc.
905 Sheehy Dr.
Horsham,  PA  19044
Correspondent Contact JOEL A MARCUS
Regulation Number878.4800
Classification Product Code
LRP  
Date Received08/17/1987
Decision Date 09/24/1987
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
-
-