The following data is part of a premarket notification filed by Copan Flock Technologies with the FDA for Copan Mswab Collection, Transport And Preservation System.
| Device ID | K121039 |
| 510k Number | K121039 |
| Device Name: | COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM |
| Classification | System, Transport, Aerobic |
| Applicant | COPAN FLOCK TECHNOLOGIES 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Cynthia Sinclair |
| Correspondent | Cynthia Sinclair COPAN FLOCK TECHNOLOGIES 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | JTW |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-05 |
| Decision Date | 2012-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 58053326006192 | K121039 | 000 |
| 58053326006185 | K121039 | 000 |