The following data is part of a premarket notification filed by Farris Laboratories, Inc. with the FDA for Sterile Empty Glass Vials.
Device ID | K883686 |
510k Number | K883686 |
Device Name: | STERILE EMPTY GLASS VIALS |
Classification | System, Delivery, Allergen And Vaccine |
Applicant | FARRIS LABORATORIES, INC. P.O. BOX 948 Desoto, TX 75123 -0948 |
Contact | John R Farris |
Correspondent | John R Farris FARRIS LABORATORIES, INC. P.O. BOX 948 Desoto, TX 75123 -0948 |
Product Code | LDH |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-29 |
Decision Date | 1988-09-23 |