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 prosthesis, breast, external, used with adhesive
510(k) Number K915382
Device Name AMOENA AFFINITY MODEL #802
Applicant
COLOPLAST CORP.
2150 NEW MARKET PARKWAY,
SUITE 116
MARIETTA,  GA  30067
Applicant Contact LEE LEWIS
Correspondent
COLOPLAST CORP.
2150 NEW MARKET PARKWAY,
SUITE 116
MARIETTA,  GA  30067
Correspondent Contact LEE LEWIS
Regulation Number878.3800
Classification Product Code
KCZ  
Date Received11/29/1991
Decision Date 01/14/1992
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
-
-