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 Material, External Aesthetic Restoration, Used With Adhesive
510(k) Number K851668
Device Name PROSTHESIS OR SURGICAL PADS
Applicant
Virginia Hall, Inc.
4331-37 Pio Nono Ave.
Macon,  GA  31206
Applicant Contact JANET L DEGRANDIS
Correspondent
Virginia Hall, Inc.
4331-37 Pio Nono Ave.
Macon,  GA  31206
Correspondent Contact JANET L DEGRANDIS
Regulation Number878.3800
Classification Product Code
GBI  
Date Received04/23/1985
Decision Date 06/04/1985
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
-
-