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 kit, surgical instrument, disposable
510(k) Number K920516
Device Name GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSAB
Applicant
TRINITY LABORATORIES, INC.
P.O. BOX 4458
201 KILEY DRIVE
SALISBURY,  MD  21803
Applicant Contact PARTHA BASUMALLIK
Correspondent
TRINITY LABORATORIES, INC.
P.O. BOX 4458
201 KILEY DRIVE
SALISBURY,  MD  21803
Correspondent Contact PARTHA BASUMALLIK
Regulation Number878.4800
Classification Product Code
KDD  
Date Received02/04/1992
Decision Date 04/16/1992
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-