510(k) K992079
K992079 is an FDA 510(k) premarket notification submitted by The Kendall Company, L.P. for the device "KENDALL MODEL 7325 SCD RESPONSE COMPRESSION SYSTEM, MODEL 7325". The FDA issued a decision of Substantially Equivalent on September 29, 1999. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. The Kendall Company, L.P. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 1999
- Date Received
- June 21, 1999
- Clearance Type
- Special
- 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