The following data is part of a premarket notification filed by Sylvan Corp. with the FDA for Sylvan Pediascan 200 Transilluminator.
| Device ID | K901309 |
| 510k Number | K901309 |
| Device Name: | SYLVAN PEDIASCAN 200 TRANSILLUMINATOR |
| Classification | Transilluminator, Battery-powered |
| Applicant | SYLVAN CORP. P.O. BOX 362, 612 CEDAR STREET Irwin, PA 15642 |
| Contact | James G Fedorka |
| Correspondent | James G Fedorka SYLVAN CORP. P.O. BOX 362, 612 CEDAR STREET Irwin, PA 15642 |
| Product Code | HJN |
| CFR Regulation Number | 886.1945 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-20 |
| Decision Date | 1990-05-24 |