The following data is part of a premarket notification filed by Orion Corp. with the FDA for Dentocult-sm Culture-paddle.
| Device ID | K872301 |
| 510k Number | K872301 |
| Device Name: | DENTOCULT-SM CULTURE-PADDLE |
| Classification | Culture Media, Selective And Differential |
| Applicant | ORION CORP. P.O. BOX 425 20101 Turku, FI |
| Contact | Timo Raines |
| Correspondent | Timo Raines ORION CORP. P.O. BOX 425 20101 Turku, FI |
| Product Code | JSI |
| CFR Regulation Number | 866.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-15 |
| Decision Date | 1987-09-11 |