The following data is part of a premarket notification filed by Phase One Disign Co. with the FDA for Ceiling Mount Counterpoised Secon Radiation Shield.
| Device ID | K861019 |
| 510k Number | K861019 |
| Device Name: | CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD |
| Classification | Screen, Leaded, Operator Radiation Protector |
| Applicant | PHASE ONE DISIGN CO. 1455-I E. FRANCISCO BLVD. San Rafael, CA 94901 |
| Contact | Melvin Magliocco |
| Correspondent | Melvin Magliocco PHASE ONE DISIGN CO. 1455-I E. FRANCISCO BLVD. San Rafael, CA 94901 |
| Product Code | EAK |
| CFR Regulation Number | 892.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-18 |
| Decision Date | 1986-04-02 |