The following data is part of a premarket notification filed by Medical Engineering Laboratory, Inc. with the FDA for Gastrointestinal Flexible Biospy Forceps.
| Device ID | K873248 |
| 510k Number | K873248 |
| Device Name: | GASTROINTESTINAL FLEXIBLE BIOSPY FORCEPS |
| Classification | Endoscopic Grasping/cutting Instrument, Non-powered |
| Applicant | MEDICAL ENGINEERING LABORATORY, INC. 108 WEST WARREN ST., SUITE 207 Shelby, NC 28150 |
| Contact | William J Young |
| Correspondent | William J Young MEDICAL ENGINEERING LABORATORY, INC. 108 WEST WARREN ST., SUITE 207 Shelby, NC 28150 |
| Product Code | OCZ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-14 |
| Decision Date | 1987-12-30 |