510(k) K991394
K991394 is an FDA 510(k) premarket notification submitted by Grace Medical, Inc. for the device "STAPES PROSTHESES". The FDA issued a decision of Substantially Equivalent on May 18, 1999. The device falls under product code ETB (Prosthesis, Partial Ossicular Replacement), a Class II device regulated under 21 CFR 874.3450. Grace Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 18, 1999
- Date Received
- April 21, 1999
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Partial Ossicular Replacement
- Device Class
- Class II
- Regulation Number
- 874.3450
- Review Panel
- EN
- Submission Type