510(k) K772168
K772168 is an FDA 510(k) premarket notification submitted by Robert B. Scott Ocularists of Florida, Inc. for the device "MOLDEYE". The FDA issued a decision of Substantially Equivalent on November 30, 1977. The device falls under product code HQN (Conformer, Ophthalmic), a Class II device regulated under 21 CFR 886.3130. Robert B. Scott Ocularists of Florida, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 1977
- Date Received
- November 8, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Conformer, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 886.3130
- Review Panel
- OP
- Submission Type