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 Splint, Extremity, Inflatable, External
510(k) Number K881516
Device Name COMPRESAID
Applicant
R. Evans Corp.
Suite 209
14040 N. Cave Creek Rd.
Phoenix,  AZ  85022
Applicant Contact ROBERT J EVANS
Correspondent
R. Evans Corp.
Suite 209
14040 N. Cave Creek Rd.
Phoenix,  AZ  85022
Correspondent Contact ROBERT J EVANS
Regulation Number878.3900
Classification Product Code
FZF  
Date Received04/11/1988
Decision Date 04/29/1988
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
-
-