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 Instrument, Manual, Surgical, General Use
510(k) Number K921022
Device Name DISPOSABLE CURETTE
Applicant
Dermtec, Inc.
P.O. Box 457
Kershaw,  SC  29067
Applicant Contact BREWER, JR.
Correspondent
Dermtec, Inc.
P.O. Box 457
Kershaw,  SC  29067
Correspondent Contact BREWER, JR.
Regulation Number878.4800
Classification Product Code
MDM  
Date Received03/03/1992
Decision Date 12/03/1992
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
Predetermined Change
Control Plan Authorized		 No
-
-