The following data is part of a premarket notification filed by Perlink Usa, Inc. with the FDA for Perlink Screen, Kiran Screen.
| Device ID | K896707 |
| 510k Number | K896707 |
| Device Name: | PERLINK SCREEN, KIRAN SCREEN |
| Classification | Screen, Intensifying, Radiographic |
| Applicant | PERLINK USA, INC. 290 STULYVESANT AVE. Rye, NY 10580 |
| Contact | Sushil K Kanwar |
| Correspondent | Sushil K Kanwar PERLINK USA, INC. 290 STULYVESANT AVE. Rye, NY 10580 |
| Product Code | EAM |
| CFR Regulation Number | 892.1960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-28 |
| Decision Date | 1990-08-30 |