510(k) K904352
K904352 is an FDA 510(k) premarket notification submitted by Codman & Shurtleff, Inc. for the device "CODMAN COLLINS RADIOPARENT STERNAL BLADES". The FDA issued a decision of Substantially Equivalent on November 21, 1990. The device falls under product code DWH (Blade, Saw, Surgical, Cardiovascular), a Class I device regulated under 21 CFR 878.4820. Codman & Shurtleff, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 1990
- Date Received
- September 24, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Blade, Saw, Surgical, Cardiovascular
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- SU
- Submission Type