510(k) K960261
K960261 is an FDA 510(k) premarket notification submitted by Alcon Laboratories, Inc. for the device "PALLIKARIS BRUSH". The FDA issued a decision of Substantially Equivalent on March 11, 1996. The device falls under product code HOG (Burr, Corneal, Battery-Powered), a Class I device regulated under 21 CFR 886.4070. Alcon Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 1996
- Date Received
- January 18, 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