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 Exerciser, Powered
510(k) Number K945221
Device Name SUTTER MODEL 6000 HAND CPM DEVICE
Applicant
Sutter Corp.
9465 Farnham St.
San Diego,  CA  92123
Applicant Contact LOUISE M FOCHT
Correspondent
Sutter Corp.
9465 Farnham St.
San Diego,  CA  92123
Correspondent Contact LOUISE M FOCHT
Regulation Number890.5380
Classification Product Code
BXB  
Date Received10/26/1994
Decision Date 02/27/1995
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
-
-