The following data is part of a premarket notification filed by Accu-med Corp. with the FDA for Accu-culshure Tm.
| Device ID | K882637 |
| 510k Number | K882637 |
| Device Name: | ACCU-CULSHURE TM |
| Classification | Transport Systems, Anaerobic |
| Applicant | ACCU-MED CORP. 270 MARBLE AVE. Pleasantville, NY 10570 |
| Contact | Joann Hanchrow |
| Correspondent | Joann Hanchrow ACCU-MED CORP. 270 MARBLE AVE. Pleasantville, NY 10570 |
| Product Code | JTX |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-27 |
| Decision Date | 1988-07-06 |