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 Container, Sharps
510(k) Number K921913
Device Name HYPO-GARD
Applicant
Epi Medical Products, Inc.
42040 Koppernick
Suite 407
Canton,  MI  48187
Applicant Contact LEE TAYLOR
Correspondent
Epi Medical Products, Inc.
42040 Koppernick
Suite 407
Canton,  MI  48187
Correspondent Contact LEE TAYLOR
Regulation Number880.5570
Classification Product Code
MMK  
Date Received04/23/1992
Decision Date 07/24/1992
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
-
-