510(k) K904511
K904511 is an FDA 510(k) premarket notification submitted by Minto Research & Development, Inc. for the device "HAND-CARRIED STRETCHERS/BREAK AWAY FLAT". The FDA issued a decision of Substantially Equivalent on October 12, 1990. The device falls under product code FPP (Stretcher, Hand-Carried), a Class I device regulated under 21 CFR 880.6900. Minto Research & Development, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 12, 1990
- Date Received
- October 2, 1990
- 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