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 Wrap, Sterilization
510(k) Number K942000
Device Name BURN DRESSING TRAY
Applicant
Medcare Custom Packaging, Inc.
Winchester St.
E Swanzey,  NH  03469
Applicant Contact WILLIAM A HAYS
Correspondent
Medcare Custom Packaging, Inc.
Winchester St.
E Swanzey,  NH  03469
Correspondent Contact WILLIAM A HAYS
Regulation Number880.6850
Classification Product Code
FRG  
Date Received04/25/1994
Decision Date 05/20/1994
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-