510(k) K811428
K811428 is an FDA 510(k) premarket notification submitted by Universal Prosthetics, Inc. for the device "NORTHWESTERN VOICE RESTORATION KIT". The FDA issued a decision of Substantially Equivalent on June 16, 1981. The device falls under product code KAC (Tube, Laryngectomy), a Class I device regulated under 21 CFR 874.4420. Universal Prosthetics, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 16, 1981
- Date Received
- May 22, 1981
- 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