The following data is part of a premarket notification filed by Fiberoptic Medical Products, Inc. with the FDA for Infinity(r) Transilluminator Examination Light.
| Device ID | K912252 |
| 510k Number | K912252 |
| Device Name: | INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | FIBEROPTIC MEDICAL PRODUCTS, INC. 4000 BELL ATLANTIC TOWER 1717 ARCH STREET Philadelphia, PA 19103 |
| Contact | John B Reiss |
| Correspondent | John B Reiss FIBEROPTIC MEDICAL PRODUCTS, INC. 4000 BELL ATLANTIC TOWER 1717 ARCH STREET Philadelphia, PA 19103 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-21 |
| Decision Date | 1991-06-27 |