The following data is part of a premarket notification filed by Fmc Corp. with the FDA for I.d. And Seakem Gtg Agaroses.
Device ID | K940037 |
510k Number | K940037 |
Device Name: | I.D. AND SEAKEM GTG AGAROSES |
Classification | Support Gels |
Applicant | FMC CORP. 1001 G STREET, N.W. SUTIE 500 WEST Washington, DC 20001 |
Contact | Melvin S Drozen |
Correspondent | Melvin S Drozen FMC CORP. 1001 G STREET, N.W. SUTIE 500 WEST Washington, DC 20001 |
Product Code | JZR |
CFR Regulation Number | 866.4900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-04 |
Decision Date | 1995-02-24 |