510(k) K760551
K760551 is an FDA 510(k) premarket notification submitted by Landmark Plastics for the device "CANNULA, LARRIAT". The FDA issued a decision of Substantially Equivalent on September 5, 1976. The device falls under product code CAT (Cannula, Nasal, Oxygen), a Class I device regulated under 21 CFR 868.5340. Landmark Plastics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 5, 1976
- Date Received
- August 30, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cannula, Nasal, Oxygen
- Device Class
- Class I
- Regulation Number
- 868.5340
- Review Panel
- AN
- Submission Type