The following data is part of a premarket notification filed by Flow Laboratories, Inc. with the FDA for F.a. Mounting Medium.
Device ID | K781388 |
510k Number | K781388 |
Device Name: | F.A. MOUNTING MEDIUM |
Classification | Media, Mounting, Water Soluble |
Applicant | FLOW LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KEQ |
CFR Regulation Number | 864.4010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-08-10 |
Decision Date | 1978-08-21 |