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 K933668
Device Name ALMOST U, INC. BREAST PROSTHESIS
Applicant
Almost U., Inc.
1006 Brown St.
Peekskill,  NY  10566
Applicant Contact FRED J BIANCO, JR.
Correspondent
Almost U., Inc.
1006 Brown St.
Peekskill,  NY  10566
Correspondent Contact FRED J BIANCO, JR.
Regulation Number878.3800
Classification Product Code
KCZ  
Date Received07/28/1993
Decision Date 12/10/1993
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
-
-