The following data is part of a premarket notification filed by Copan Italia Spa with the FDA for Copan Venturi Transystem Amies Medium Without Charcoal.
| Device ID | K972448 |
| 510k Number | K972448 |
| Device Name: | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL |
| Classification | Culture Media, Anaerobic Transport |
| Applicant | COPAN ITALIA SPA 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia A Sinclair |
| Correspondent | Cynthia A Sinclair COPAN ITALIA SPA 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | JSL |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-30 |
| Decision Date | 1997-08-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 58053326008875 | K972448 | 000 |
| 38053326000585 | K972448 | 000 |
| 38053326000592 | K972448 | 000 |
| 38053326001216 | K972448 | 000 |
| 38053326001575 | K972448 | 000 |
| 58053326001609 | K972448 | 000 |
| 58053326001821 | K972448 | 000 |
| 58053326001838 | K972448 | 000 |
| 58053326001845 | K972448 | 000 |
| 58053326001852 | K972448 | 000 |
| 58053326002064 | K972448 | 000 |
| 58053326008714 | K972448 | 000 |
| 58053326008745 | K972448 | 000 |
| 58053326008752 | K972448 | 000 |
| 58053326008790 | K972448 | 000 |
| 58053326002071 | K972448 | 000 |