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 Bedding, Disposable, Medical
510(k) Number K912257
Device Name CHEM-SLEEVE B
Applicant
Haz-Med, Inc.
233 Felch St.
Holland,  MI  49424
Applicant Contact DAVID B WEEKS
Correspondent
Haz-Med, Inc.
233 Felch St.
Holland,  MI  49424
Correspondent Contact DAVID B WEEKS
Regulation Number880.6060
Classification Product Code
KME  
Date Received05/22/1991
Decision Date 12/31/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-