510(k) K801330
K801330 is an FDA 510(k) premarket notification submitted by The Anspach Effort, Inc. for the device "ANSPACH LEG SUPPORT". The FDA issued a decision of Substantially Equivalent on June 26, 1980. The device falls under product code CCX (Support, Patient Position), a Class I device regulated under 21 CFR 868.6820. The Anspach Effort, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 26, 1980
- Date Received
- June 3, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Support, Patient Position
- Device Class
- Class I
- Regulation Number
- 868.6820
- Review Panel
- AN
- Submission Type