The following data is part of a premarket notification filed by Kinetic Biomedical Services, Inc. with the FDA for Kinetic Model 500.
| Device ID | K891756 |
| 510k Number | K891756 |
| Device Name: | KINETIC MODEL 500 |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | KINETIC BIOMEDICAL SERVICES, INC. 4934 PEACH ST. Erie, PA 16509 |
| Contact | James I Laughner |
| Correspondent | James I Laughner KINETIC BIOMEDICAL SERVICES, INC. 4934 PEACH ST. Erie, PA 16509 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-23 |
| Decision Date | 1989-04-19 |