The following data is part of a premarket notification filed by The Hygenic Corp. with the FDA for Tray Dough.
| Device ID | K911225 |
| 510k Number | K911225 |
| Device Name: | TRAY DOUGH |
| Classification | Retention Device, Suture |
| Applicant | THE HYGENIC CORP. 1245 HOME AVE. Akron, OH 44310 -2575 |
| Contact | T. N Meyer |
| Correspondent | T. N Meyer THE HYGENIC CORP. 1245 HOME AVE. Akron, OH 44310 -2575 |
| Product Code | KGS |
| CFR Regulation Number | 878.4930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-21 |
| Decision Date | 1991-04-17 |