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 Elastomer, Silicone, For Scar Management
510(k) Number K934829
Device Name HASKON MEDICAL GRADE SHEETING
Applicant
Haskon Intl., Inc.
336 Weir St.
Taunton,  MA  02780
Applicant Contact LOURDES V CONCEPCION
Correspondent
Haskon Intl., Inc.
336 Weir St.
Taunton,  MA  02780
Correspondent Contact LOURDES V CONCEPCION
Regulation Number878.4025
Classification Product Code
MDA  
Date Received10/08/1993
Decision Date 02/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-