The following data is part of a premarket notification filed by Epi Medical Products, Inc. with the FDA for Hypo-gard.
| Device ID | K921913 | 
| 510k Number | K921913 | 
| Device Name: | HYPO-GARD | 
| Classification | Container, Sharps | 
| Applicant | EPI MEDICAL PRODUCTS, INC. 42040 KOPPERNICK SUITE 407 Canton, MI 48187 | 
| Contact | Lee Taylor | 
| Correspondent | Lee Taylor EPI MEDICAL PRODUCTS, INC. 42040 KOPPERNICK SUITE 407 Canton, MI 48187 | 
| Product Code | MMK | 
| CFR Regulation Number | 880.5570 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1992-04-23 | 
| Decision Date | 1992-07-24 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  HYPO-GARD  74202480  1800613 Dead/Cancelled | EPI Medical Products, Inc. 1991-09-06 | 
|  HYPO-GARD  74201333  1756632 Dead/Cancelled | EPI Medical Products, Inc. 1991-09-06 |