510(k) K760330
K760330 is an FDA 510(k) premarket notification submitted by Inhal-O-Tech Medical Plastic for the device "CANNULA, DISPOSABLE OXYGEN TTHERAPY". The FDA issued a decision of Substantially Equivalent on Aug 4, 1976. The device falls under product code CAT (Cannula, Nasal, Oxygen), a Class I device regulated under 21 CFR 868.5340. Inhal-O-Tech Medical Plastic has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 4, 1976
- Date Received
- Jul 28, 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