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 Dressing, Wound, Drug
510(k) Number K922729
Device Name SPARTA WET DRESSING, SODIUM CHLORIDE
Applicant
Sparta Surgical Corp.
368 Fairview Ave.
P.O. Box 268
Hammonton,  NJ  08037
Applicant Contact CARLETON F KIMBER
Correspondent
Sparta Surgical Corp.
368 Fairview Ave.
P.O. Box 268
Hammonton,  NJ  08037
Correspondent Contact CARLETON F KIMBER
Classification Product Code
FRO  
Date Received06/05/1992
Decision Date 11/23/1992
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-