510(k) K921803
K921803 is an FDA 510(k) premarket notification submitted by Molecular Products , Ltd. for the device "SOFNOLIME CARBON DIOXIDE ABSORBENT". The FDA issued a decision of Substantially Equivalent on October 15, 1992. The device falls under product code CBL (Absorbent, Carbon-Dioxide), a Class I device regulated under 21 CFR 868.5300. Molecular Products , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 15, 1992
- Date Received
- April 15, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Absorbent, Carbon-Dioxide
- Device Class
- Class I
- Regulation Number
- 868.5300
- Review Panel
- AN
- Submission Type