The following data is part of a premarket notification filed by D&r X-ray Products, Inc. with the FDA for Collimator Model A280blmd & Model A280blmp.
| Device ID | K861941 |
| 510k Number | K861941 |
| Device Name: | COLLIMATOR MODEL A280BLMD & MODEL A280BLMP |
| Classification | Collimator, Manual, Radiographic |
| Applicant | D&R X-RAY PRODUCTS, INC. 2428 HANOVER AVE. Richmond, VA 23220 |
| Contact | David P Armstrong |
| Correspondent | David P Armstrong D&R X-RAY PRODUCTS, INC. 2428 HANOVER AVE. Richmond, VA 23220 |
| Product Code | IZX |
| CFR Regulation Number | 892.1610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-20 |
| Decision Date | 1986-07-25 |