510(k) K874252
K874252 is an FDA 510(k) premarket notification submitted by Richmond Products, Inc. for the device "KREDA DISC". The FDA issued a decision of Substantially Equivalent on January 27, 1988. The device falls under product code HOQ (Grid, Amsler), a Class I device regulated under 21 CFR 886.1330. Richmond Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 1988
- Date Received
- October 19, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Grid, Amsler
- Device Class
- Class I
- Regulation Number
- 886.1330
- Review Panel
- OP
- Submission Type