510(k) K831773
K831773 is an FDA 510(k) premarket notification submitted by Bcd Products, Inc. for the device "MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK". The FDA issued a decision of Substantially Equivalent on August 16, 1983. The device falls under product code HQJ (Implant, Absorbable, (Scleral Buckling Methods)), a Class II device regulated under 21 CFR 886.3300. Bcd Products, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 1983
- Date Received
- June 2, 1983
- 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