510(k) K911765
K911765 is an FDA 510(k) premarket notification submitted by L.E. Phillips Career Development Center, Inc. for the device "HAND CARRIED STRETCHER". The FDA issued a decision of Substantially Equivalent on June 14, 1991. The device falls under product code FPP (Stretcher, Hand-Carried), a Class I device regulated under 21 CFR 880.6900.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 14, 1991
- Date Received
- April 19, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stretcher, Hand-Carried
- Device Class
- Class I
- Regulation Number
- 880.6900
- Review Panel
- HO
- Submission Type