The following data is part of a premarket notification filed by Medie Group with the FDA for Dr. Hessel's Insect Poison Remover.
| Device ID | K844048 |
| 510k Number | K844048 |
| Device Name: | DR. HESSEL'S INSECT POISON REMOVER |
| Classification | Snake Bite Suction Kit |
| Applicant | MEDIE GROUP 1819 HE ST. NW FEDERAL BAR BLDG. Washington, DC 20006 |
| Contact | Randi L Breslow |
| Correspondent | Randi L Breslow MEDIE GROUP 1819 HE ST. NW FEDERAL BAR BLDG. Washington, DC 20006 |
| Product Code | KYP |
| CFR Regulation Number | 880.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-17 |
| Decision Date | 1985-01-23 |