510(k) K831975
K831975 is an FDA 510(k) premarket notification submitted by Surgidev Corp. for the device "LEADING EDGE OPHTHALMIC KNIFE". The FDA issued a decision of Substantially Equivalent on Aug 31, 1983. The device falls under product code HNN (Knife, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Surgidev Corp. has 3 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 31, 1983
- Date Received
- Jun 20, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Knife, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.4350
- Review Panel
- OP
- Submission Type
- 510(k) Exempt