The following data is part of a premarket notification filed by Remel Co. with the FDA for Bacti-swab.
Device ID | K910180 |
510k Number | K910180 |
Device Name: | BACTI-SWAB |
Classification | Culture Media, Non-propagating Transport |
Applicant | REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
Contact | Ann Silvius |
Correspondent | Ann Silvius REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
Product Code | JSM |
CFR Regulation Number | 866.2390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-01-15 |
Decision Date | 1991-05-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BACTI-SWAB 76447402 2717516 Live/Registered |
Remel Inc. 2002-09-06 |