510(k) K781411
K781411 is an FDA 510(k) premarket notification submitted by Codman & Shurtleff, Inc. for the device "CORNEAL CUTTER AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on September 20, 1978. The device falls under product code HRH (Trephine, Manual, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Codman & Shurtleff, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 1978
- Date Received
- August 15, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Trephine, Manual, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.4350
- Review Panel
- OP
- Submission Type