510(k) K897119
K897119 is an FDA 510(k) premarket notification submitted by Grieshaber & Co. for the device "GRIESHABER RETINAL TACK AND SUTHERLAND TACK FORCEP". The FDA issued a decision of Substantially Equivalent on April 12, 1990. The device falls under product code HQW (Clip, Tantalum, Ophthalmic), a Class II device regulated under 21 CFR 886.3100. Grieshaber & Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 1990
- Date Received
- December 26, 1989
- 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