The following data is part of a premarket notification filed by Gibson Laboratories, Inc. with the FDA for Saf Fixative.
Device ID | K905120 |
510k Number | K905120 |
Device Name: | SAF FIXATIVE |
Classification | Device, Specimen Collection |
Applicant | GIBSON LABORATORIES, INC. 1040 MANCHESTER ST. Lexington, KY 40508 |
Contact | Cecil Gibson |
Correspondent | Cecil Gibson GIBSON LABORATORIES, INC. 1040 MANCHESTER ST. Lexington, KY 40508 |
Product Code | LIO |
CFR Regulation Number | 866.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-14 |
Decision Date | 1990-12-17 |