510(k) K896472
K896472 is an FDA 510(k) premarket notification submitted by Key Surgical, Inc. for the device "KEY VASCULAR BOOTIES". The FDA issued a decision of Substantially Equivalent on December 14, 1989. The device falls under product code MAW (Marker, Suture Identification), a Class I device regulated under 21 CFR 878.4800. Key Surgical, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 1989
- Date Received
- November 13, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Marker, Suture Identification
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type