The following data is part of a premarket notification filed by Puritan Medical Products Llc with the FDA for Puritan Fecal Opti-swab Collection And Transport System.
| Device ID | K162284 |
| 510k Number | K162284 |
| Device Name: | Puritan Fecal Opti-Swab Collection And Transport System |
| Classification | Culture Media, Non-propagating Transport |
| Applicant | PURITAN MEDICAL PRODUCTS LLC 31 SCHOOL STREET P.O. BOX 149 Guilford, ME 04443 |
| Contact | Mehdi Karamchi |
| Correspondent | Mehdi Karamchi PURITAN MEDICAL PRODUCTS LLC 31 SCHOOL STREET P.O. BOX 149 Guilford, ME 04443 |
| Product Code | JSM |
| Subsequent Product Code | JTW |
| Subsequent Product Code | JTX |
| Subsequent Product Code | LIO |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-15 |
| Decision Date | 2016-11-04 |
| Summary: | summary |