K903973 is an FDA 510(k) clearance for the GARDOSI BIRTHING CUSHION. This device is classified as a Table, Obstetric (and Accessories) (Class II - Special Controls, product code KNC).
Submitted by Graphic Controls Corp. (Buffalo, US). The FDA issued a Cleared decision on September 27, 1990, 30 days after receiving the submission on August 28, 1990.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4900.
| 510(k) Number | K903973 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 1990 |
| Decision Date | September 27, 1990 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | KNC — Table, Obstetric (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4900 |