510(k) K981526
K981526 is an FDA 510(k) premarket notification submitted by Ace Surgical Supply Co., Inc. for the device "ACE ALVEOLAR DISTRACTOR". The FDA issued a decision of Substantially Equivalent on November 6, 1998. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Ace Surgical Supply Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 1998
- Date Received
- April 28, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Bone
- Device Class
- Class II
- Regulation Number
- 872.4760
- Review Panel
- DE
- Submission Type