510(k) K940037
K940037 is an FDA 510(k) premarket notification submitted by Fmc Corp. for the device "I.D. AND SEAKEM GTG AGAROSES". The FDA issued a decision of Substantially Equivalent on February 24, 1995. The device falls under product code JZR (Support Gels), a Class I device regulated under 21 CFR 866.4900. Fmc Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 1995
- Date Received
- January 4, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Support Gels
- Device Class
- Class I
- Regulation Number
- 866.4900
- Review Panel
- IM
- Submission Type