The following data is part of a premarket notification filed by Byers Industries, Inc. with the FDA for Figleaf Shield.
| Device ID | K930763 |
| 510k Number | K930763 |
| Device Name: | FIGLEAF SHIELD |
| Classification | Shield, Gonadal |
| Applicant | BYERS INDUSTRIES, INC. 6955 S.W. SANDBURG ST. Portland, OR 97223 -9969 |
| Contact | Charles J Storm |
| Correspondent | Charles J Storm BYERS INDUSTRIES, INC. 6955 S.W. SANDBURG ST. Portland, OR 97223 -9969 |
| Product Code | IWT |
| CFR Regulation Number | 892.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-12 |
| Decision Date | 1993-05-17 |