510(k) K973849
K973849 is an FDA 510(k) premarket notification submitted by Hogan & Hartson for the device "BIOABSORBABLE BANKART TACK". The FDA issued a decision of Substantially Equivalent on January 6, 1998. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Hogan & Hartson has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 6, 1998
- Date Received
- October 8, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fastener, Fixation, Biodegradable, Soft Tissue
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type