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 Board, Arm (With Cover), Sterile
510(k) Number K881292
Device Name ALLEN LATERAL ARMBOARD
Applicant
Edgewater Medical Systems, Inc.
6263 Mayfield Rd. #206
Mayfield Hts.,  OH  44124
Applicant Contact DANIEL ALLEN
Correspondent
Edgewater Medical Systems, Inc.
6263 Mayfield Rd. #206
Mayfield Hts.,  OH  44124
Correspondent Contact DANIEL ALLEN
Regulation Number878.3910
Classification Product Code
BTX  
Date Received03/28/1988
Decision Date 04/07/1988
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
-
-