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
510(k) Number K853185
Device Name CUDDLE CUSHION
Applicant
The Cuddle Co.
P.O. Box 22272
Chattanooga,  TN  37422
Applicant Contact GARY R KEEL
Correspondent
The Cuddle Co.
P.O. Box 22272
Chattanooga,  TN  37422
Correspondent Contact GARY R KEEL
Classification Product Code
LDQ
Date Received07/30/1985
Decision Date 08/20/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-