510(k) K772419
K772419 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "HEEL OR ELBOW PROTECTOR". The FDA issued a decision of Substantially Equivalent on January 26, 1978. The device falls under product code FMP (Protector, Skin Pressure), a Class I device regulated under 21 CFR 880.6450. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 1978
- Date Received
- December 27, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Protector, Skin Pressure
- Device Class
- Class I
- Regulation Number
- 880.6450
- Review Panel
- HO
- Submission Type