510(k) K962989
K962989 is an FDA 510(k) premarket notification submitted by S. Percy Amoils for the device "AMOILS EPITHELIAL SCRUBBER". The FDA issued a decision of Substantially Equivalent on January 9, 1997. The device falls under product code HOG (Burr, Corneal, Battery-Powered), a Class I device regulated under 21 CFR 886.4070.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 1997
- Date Received
- August 1, 1996
- 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