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 Gauze/Sponge, Internal
510(k) Number K945004
Device Name 2, 3 & 4 BANDADGE COMPRESS
Applicant
Certified Safety Mfg., Inc.
1400 Chestnut
Kansas City,  MO  64127
Applicant Contact HOWARD FREEDMAN
Correspondent
Certified Safety Mfg., Inc.
1400 Chestnut
Kansas City,  MO  64127
Correspondent Contact HOWARD FREEDMAN
Classification Product Code
EFQ  
Date Received10/13/1994
Decision Date 03/22/1995
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-