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, Occlusive
510(k) Number K860085
Device Name LYOFOAM WOUND DRESSINGS
Applicant
Acme United Corp.
425 Post Rd.
Fairfield,  CT  06430
Applicant Contact SUSAN L CAREY
Correspondent
Acme United Corp.
425 Post Rd.
Fairfield,  CT  06430
Correspondent Contact SUSAN L CAREY
Regulation Number878.4020
Classification Product Code
NAD  
Date Received01/09/1986
Decision Date 06/27/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-