510(k) K892349
K892349 is an FDA 510(k) premarket notification submitted by Coburn Optical Ind., Inc. for the device "MAGNILINK SYSTEM 209". The FDA issued a decision of Substantially Equivalent on May 26, 1989. The device falls under product code HJG (System, Reading, Television, Closed-Circuit), a Class I device regulated under 21 CFR 886.5820. Coburn Optical Ind., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 1989
- Date Received
- April 5, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Reading, Television, Closed-Circuit
- Device Class
- Class I
- Regulation Number
- 886.5820
- Review Panel
- OP
- Submission Type