The following data is part of a premarket notification filed by Mercury Enterprises, Inc. with the FDA for Genny Denny Iv Shield.
| Device ID | K885342 |
| 510k Number | K885342 |
| Device Name: | GENNY DENNY IV SHIELD |
| Classification | Lancet, Blood |
| Applicant | MERCURY ENTERPRISES, INC. 11300 A-49TH ST. NORTH Clearwater, FL 34622 |
| Contact | Arthur J Ward |
| Correspondent | Arthur J Ward MERCURY ENTERPRISES, INC. 11300 A-49TH ST. NORTH Clearwater, FL 34622 |
| Product Code | FMK |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-28 |
| Decision Date | 1989-03-30 |