The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Gardosi Birthing Cushion.
| Device ID | K903973 |
| 510k Number | K903973 |
| Device Name: | GARDOSI BIRTHING CUSHION |
| Classification | Table, Obstetric (and Accessories) |
| Applicant | GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1274 Buffalo, NY 14240 |
| Contact | Albert Amelotte |
| Correspondent | Albert Amelotte GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1274 Buffalo, NY 14240 |
| Product Code | KNC |
| CFR Regulation Number | 884.4900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-28 |
| Decision Date | 1990-09-27 |