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 Block
510(k) Number K022511
Device Name AART CALF IMPLANT
Applicant
Aesthetic and Reconstructive Technologies, Inc.
5871 Lone Pine Place
Paso Robles,  CA  93446
Applicant Contact CATHERINE RIPLE
Correspondent
Aesthetic and Reconstructive Technologies, Inc.
5871 Lone Pine Place
Paso Robles,  CA  93446
Correspondent Contact CATHERINE RIPLE
Regulation Number874.3620
Classification Product Code
MIB  
Date Received07/30/2002
Decision Date 08/26/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-