510(k) K791763
K791763 is an FDA 510(k) premarket notification submitted by Intl. Ophthalmic Industries Corp. for the device "(MICRO-KERATRON, MICRO DUCT TREPHINE)". The FDA issued a decision of Substantially Equivalent on November 5, 1979. The device falls under product code HRG (Engine, Trephine, Accessories, Ac-Powered), a Class I device regulated under 21 CFR 886.4070. Intl. Ophthalmic Industries Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 1979
- Date Received
- September 5, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Engine, Trephine, Accessories, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 886.4070
- Review Panel
- OP
- Submission Type