510(k) K913421
K913421 is an FDA 510(k) premarket notification submitted by Specialty Packaging Producs, Inc. for the device "NASAL OXYGEN CANNULA, 81585, 81587 & 81589". The FDA issued a decision of Substantially Equivalent on October 18, 1991. The device falls under product code CAT (Cannula, Nasal, Oxygen), a Class I device regulated under 21 CFR 868.5340. Specialty Packaging Producs, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 1991
- Date Received
- July 31, 1991
- 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