The following data is part of a premarket notification filed by Medical Products Development, Inc. with the FDA for Surg-flex 15 Surgical Light.
| Device ID | K810019 |
| 510k Number | K810019 |
| Device Name: | SURG-FLEX 15 SURGICAL LIGHT |
| Classification | Light, Surgical, Instrument |
| Applicant | MEDICAL PRODUCTS DEVELOPMENT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FSQ |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-05 |
| Decision Date | 1981-01-23 |