The following data is part of a premarket notification filed by Kenlor Industries, Inc. with the FDA for Kenlor H. Pylori Control Serum.
| Device ID | K964014 |
| 510k Number | K964014 |
| Device Name: | KENLOR H. PYLORI CONTROL SERUM |
| Classification | Helicobacter Pylori |
| Applicant | KENLOR INDUSTRIES, INC. 1560 EAST EDINGER AVE., SUITE A-1 Santa Ana, CA 92705 |
| Contact | Kamales Som |
| Correspondent | Kamales Som KENLOR INDUSTRIES, INC. 1560 EAST EDINGER AVE., SUITE A-1 Santa Ana, CA 92705 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-07 |
| Decision Date | 1997-03-03 |
| Summary: | summary |