510(k) K821306
K821306 is an FDA 510(k) premarket notification submitted by Med-Life, Inc. for the device "HEAD-UP SUPINE SAFETY SUPPORT CUSHION". The FDA issued a decision of Substantially Equivalent on June 7, 1982. The device falls under product code EPW (Support, Head, Surgical, Ent), a Class I device regulated under 21 CFR 878.4950. Med-Life, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 7, 1982
- Date Received
- May 4, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Support, Head, Surgical, Ent
- Device Class
- Class I
- Regulation Number
- 878.4950
- Review Panel
- SU
- Submission Type