510(k) K883295
K883295 is an FDA 510(k) premarket notification submitted by Avec Scientific Design Corp. for the device "CHOP SPINE FRAME". The FDA issued a decision of Substantially Equivalent on August 23, 1988. The device falls under product code LWG (Surgical Table Cushion), a Class I device regulated under 21 CFR 878.4950. Avec Scientific Design Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 1988
- Date Received
- August 4, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Surgical Table Cushion
- Device Class
- Class I
- Regulation Number
- 878.4950
- Review Panel
- SU
- Submission Type