510(k) K873932
K873932 is an FDA 510(k) premarket notification submitted by Molecular Biosystems, Inc. for the device "THE EXTRACTOR(TM)". The FDA issued a decision of Substantially Equivalent on November 20, 1987. The device falls under product code DKO (Adsorbents, Ion-Exchange), a Class I device regulated under 21 CFR 862.2230. Molecular Biosystems, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 1987
- Date Received
- September 25, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adsorbents, Ion-Exchange
- Device Class
- Class I
- Regulation Number
- 862.2230
- Review Panel
- TX
- Submission Type