510(k) K961405
K961405 is an FDA 510(k) premarket notification submitted by Alba-Waldensian, Inc. for the device "ALBA HEALTH PAS WRAP SYSTEM". The FDA issued a decision of Substantially Equivalent on December 26, 1996. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Alba-Waldensian, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 26, 1996
- Date Received
- April 11, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sleeve, Limb, Compressible
- Device Class
- Class II
- Regulation Number
- 870.5800
- Review Panel
- CV
- Submission Type