510(k) K901275
K901275 is an FDA 510(k) premarket notification submitted by Alcon Surgical, Inc. for the device "RETINAL TAAK". The FDA issued a decision of Substantially Equivalent on March 23, 1990. The device falls under product code HQW (Clip, Tantalum, Ophthalmic), a Class II device regulated under 21 CFR 886.3100. Alcon Surgical, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 1990
- Date Received
- March 19, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Tantalum, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 886.3100
- Review Panel
- OP
- Submission Type