The following data is part of a premarket notification filed by North Coast Medi-tek with the FDA for Biopsy Tray I & Ii.
| Device ID | K854095 |
| 510k Number | K854095 |
| Device Name: | BIOPSY TRAY I & II |
| Classification | General Surgery Tray |
| Applicant | NORTH COAST MEDI-TEK 1520-B EAST 365 ST. Eastlake, OH 44094 |
| Contact | Theresa Sololoski |
| Correspondent | Theresa Sololoski NORTH COAST MEDI-TEK 1520-B EAST 365 ST. Eastlake, OH 44094 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-07 |
| Decision Date | 1985-11-25 |