510(k) K945727
K945727 is an FDA 510(k) premarket notification submitted by Catco Medical, Inc. for the device "CATCO NEONATAL PALATE GUARD". The FDA issued a decision of Substantially Equivalent on December 7, 1994. The device falls under product code BRW (Protector, Dental), a Class I device regulated under 21 CFR 868.5820. Catco Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 1994
- Date Received
- November 22, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Protector, Dental
- Device Class
- Class I
- Regulation Number
- 868.5820
- Review Panel
- AN
- Submission Type