The following data is part of a premarket notification filed by Primed, Inc. with the FDA for Primed Rigid Container System.
| Device ID | K944864 |
| 510k Number | K944864 |
| Device Name: | PRIMED RIGID CONTAINER SYSTEM |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | PRIMED, INC. 1015 CANDIA RD. Manchester, NH 03109 -5207 |
| Contact | Robin Bush |
| Correspondent | Robin Bush PRIMED, INC. 1015 CANDIA RD. Manchester, NH 03109 -5207 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-03 |
| Decision Date | 1994-12-20 |