510(k) K950520
K950520 is an FDA 510(k) premarket notification submitted by Aaron Medical Industries for the device "BURR, CORNEAL, BATTERY-POWERED". The FDA issued a decision of Substantially Equivalent on May 2, 1995. The device falls under product code HOG (Burr, Corneal, Battery-Powered), a Class I device regulated under 21 CFR 886.4070. Aaron Medical Industries has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 1995
- Date Received
- February 6, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Burr, Corneal, Battery-Powered
- Device Class
- Class I
- Regulation Number
- 886.4070
- Review Panel
- OP
- Submission Type