The following data is part of a premarket notification filed by Catco Medical, Inc. with the FDA for Catco Neonatal Palate Guard.
| Device ID | K945727 |
| 510k Number | K945727 |
| Device Name: | CATCO NEONATAL PALATE GUARD |
| Classification | Protector, Dental |
| Applicant | CATCO MEDICAL, INC. 9010 FOXLAND DR. San Antonio, TX 78230 |
| Contact | Clyde N Baker |
| Correspondent | Clyde N Baker CATCO MEDICAL, INC. 9010 FOXLAND DR. San Antonio, TX 78230 |
| Product Code | BRW |
| CFR Regulation Number | 868.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-22 |
| Decision Date | 1994-12-07 |