510(k) K912765
K912765 is an FDA 510(k) premarket notification submitted by Arch Development Group for the device "STASIS BUTTON PRSSURE DEVICE". The FDA issued a decision of Substantially Equivalent on Aug 12, 1991. The device falls under product code MHW (Dressing, Compression), a Class I device regulated under 21 CFR 880.5075. Arch Development Group has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 12, 1991
- Date Received
- Jun 24, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Compression
- Device Class
- Class I
- Regulation Number
- 880.5075
- Review Panel
- SU
- Submission Type