The following data is part of a premarket notification filed by Janin Group, Inc. with the FDA for Flex-neck Pd Catheter.
| Device ID | K970159 |
| 510k Number | K970159 |
| Device Name: | FLEX-NECK PD CATHETER |
| Classification | Catheter, Peritoneal, Long-term Indwelling |
| Applicant | JANIN GROUP, INC. 615 ENTERPRISE ST. Aurora, IL 60504 -8138 |
| Contact | Pamela L Swatkowski |
| Correspondent | Pamela L Swatkowski JANIN GROUP, INC. 615 ENTERPRISE ST. Aurora, IL 60504 -8138 |
| Product Code | FJS |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-16 |
| Decision Date | 1997-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450330170 | K970159 | 000 |
| 10884450170349 | K970159 | 000 |
| 20884450170339 | K970159 | 000 |
| 10884450170325 | K970159 | 000 |
| 10884450170301 | K970159 | 000 |
| 20884450170292 | K970159 | 000 |
| 10884450170219 | K970159 | 000 |
| 20884450170209 | K970159 | 000 |
| 10884450170196 | K970159 | 000 |
| 20884450170186 | K970159 | 000 |
| 10884450305888 | K970159 | 000 |
| 10884450305925 | K970159 | 000 |
| 10884450330163 | K970159 | 000 |
| 10884450330156 | K970159 | 000 |
| 10884450330149 | K970159 | 000 |
| 20884450330139 | K970159 | 000 |
| 10884450330125 | K970159 | 000 |
| 10884450330118 | K970159 | 000 |
| 10884450330101 | K970159 | 000 |
| 10884450330095 | K970159 | 000 |
| 20884450305960 | K970159 | 000 |
| 10884450170035 | K970159 | 000 |