The following data is part of a premarket notification filed by Flents Products Co., Inc. with the FDA for #903 Silaflex Ii.
| Device ID | K915739 |
| 510k Number | K915739 |
| Device Name: | #903 SILAFLEX II |
| Classification | Protector, Hearing (insert) |
| Applicant | FLENTS PRODUCTS CO., INC. P.O. BOX 2109 Norwalk, CT 06852 |
| Contact | Peter C Kohn |
| Correspondent | Peter C Kohn FLENTS PRODUCTS CO., INC. P.O. BOX 2109 Norwalk, CT 06852 |
| Product Code | EWD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-16 |
| Decision Date | 1992-06-30 |