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 |