510(k) K890314
K890314 is an FDA 510(k) premarket notification submitted by Richard-Allan Medical Ind., Inc. for the device "PROTECTOR (SURGICAL INSTRUMENT)". The FDA issued a decision of Substantially Equivalent on February 27, 1989. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570. Richard-Allan Medical Ind., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 1989
- Date Received
- January 23, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Container, Sharps
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type