510(k) K893415
K893415 is an FDA 510(k) premarket notification submitted by Ruggles Corp. for the device "TRANS-ORAL DEPTH GAUGE". The FDA issued a decision of Substantially Equivalent on June 7, 1989. The device falls under product code LYQ (Accessories, Fixation, Spinal Intervertebral Body), a Class I device regulated under 21 CFR 888.4540. Ruggles Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 7, 1989
- Date Received
- May 2, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Fixation, Spinal Intervertebral Body
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type