510(k) K881516
K881516 is an FDA 510(k) premarket notification submitted by R. Evans Corp. for the device "COMPRESAID". The FDA issued a decision of Substantially Equivalent on April 29, 1988. The device falls under product code FZF (Splint, Extremity, Inflatable, External), a Class I device regulated under 21 CFR 878.3900.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 1988
- Date Received
- April 11, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Splint, Extremity, Inflatable, External
- Device Class
- Class I
- Regulation Number
- 878.3900
- Review Panel
- SU
- Submission Type