510(k) K935220
K935220 is an FDA 510(k) premarket notification submitted by Paladin Medical, Inc. for the device "CORE PREVENT MATTRESS MODIFICATION". The FDA issued a decision of Substantially Equivalent on November 29, 1993. The device falls under product code FMW (Cover, Mattress (Medical Purposes)), a Class I device regulated under 21 CFR 880.6190. Paladin Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 1993
- Date Received
- October 12, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cover, Mattress (Medical Purposes)
- Device Class
- Class I
- Regulation Number
- 880.6190
- Review Panel
- HO
- Submission Type