• 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 Pack, Hot Or Cold, Disposable
510(k) Number K790993
Device Name INSTANT HOT & COLD PACKS
Applicant
Chase Mfg. Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Chase Mfg. Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5710
Classification Product Code
IMD  
Date Received05/29/1979
Decision Date 09/07/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
-
-