The following data is part of a premarket notification filed by Medical Energy, Inc. with the FDA for Sl-100 Nd:yag Laser For Gastrointestinal Bleeding.
| Device ID | K871515 |
| 510k Number | K871515 |
| Device Name: | SL-100 ND:YAG LASER FOR GASTROINTESTINAL BLEEDING |
| Classification | Laser For Gastro-urology Use |
| Applicant | MEDICAL ENERGY, INC. 8518 PUNTA LORA Pensacola, FL 32514 |
| Contact | David P Lewing |
| Correspondent | David P Lewing MEDICAL ENERGY, INC. 8518 PUNTA LORA Pensacola, FL 32514 |
| Product Code | LNK |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-20 |
| Decision Date | 1987-07-09 |