510(k) K863686
K863686 is an FDA 510(k) premarket notification submitted by Brenner Metal Prod Corp. for the device "BACK REST, LITTER, NON-ADJUSTABLE". The FDA issued a decision of Substantially Equivalent on January 20, 1987. The device falls under product code FPP (Stretcher, Hand-Carried), a Class I device regulated under 21 CFR 880.6900. Brenner Metal Prod Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 20, 1987
- Date Received
- September 19, 1986
- 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