510(k) K821993
K821993 is an FDA 510(k) premarket notification submitted by Shiley, Inc. for the device "SHILEY LARYNGECTOMY TUBE". The FDA issued a decision of Substantially Equivalent on August 12, 1982. The device falls under product code KAC (Tube, Laryngectomy), a Class I device regulated under 21 CFR 874.4420. Shiley, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 1982
- Date Received
- July 7, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Laryngectomy
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type