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 General Surgery Tray
510(k) Number K934028
Device Name STERILE DRESSING CHANGE TRAY
Applicant
Surgipro, Inc.
P.O. Box 2010
Palm Florida,  FL  34682
Applicant Contact PATRICK J LAMB
Correspondent
Surgipro, Inc.
P.O. Box 2010
Palm Florida,  FL  34682
Correspondent Contact PATRICK J LAMB
Regulation Number878.4370
Classification Product Code
LRO  
Subsequent Product Code
FRG  
Date Received08/17/1993
Decision Date 02/17/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-