510(k) K790057
K790057 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "CATHETER, OXYGEN". The FDA issued a decision of Substantially Equivalent on February 5, 1979. The device falls under product code BZB (Catheter, Nasal, Oxygen), a Class I device regulated under 21 CFR 868.5350. Medline Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 1979
- Date Received
- January 9, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Nasal, Oxygen
- Device Class
- Class I
- Regulation Number
- 868.5350
- Review Panel
- AN
- Submission Type