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 Drape, Surgical
510(k) Number K882494
Device Name ELAN-E DISPOSALBE DRAPE
Applicant
DERMACARE PRODUCTS, INC.
7651 NATIONAL TURNPIKE
LOUISVILLE,  KT  40214
Applicant Contact KEN J POTTS
Correspondent
DERMACARE PRODUCTS, INC.
7651 NATIONAL TURNPIKE
LOUISVILLE,  KT  40214
Correspondent Contact KEN J POTTS
Regulation Number878.4370
Classification Product Code
KKX  
Date Received06/16/1988
Decision Date 07/08/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-