510(k) K884362
K884362 is an FDA 510(k) premarket notification submitted by Bausch & Lomb Pharmaceutical, Inc. for the device "LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD". The FDA issued a decision of Substantially Equivalent on November 29, 1988. The device falls under product code HQJ (Implant, Absorbable, (Scleral Buckling Methods)), a Class II device regulated under 21 CFR 886.3300. Bausch & Lomb Pharmaceutical, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 1988
- Date Received
- October 20, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Absorbable, (Scleral Buckling Methods)
- Device Class
- Class II
- Regulation Number
- 886.3300
- Review Panel
- OP
- Submission Type