The following data is part of a premarket notification filed by Lantor Group with the FDA for Lantor Cube Sterilizer Test Pack.
| Device ID | K882756 |
| 510k Number | K882756 |
| Device Name: | LANTOR CUBE STERILIZER TEST PACK |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | LANTOR GROUP ST. HELENS ROAD BOLTON BL3 3PR England, GB |
| Contact | Thornber |
| Correspondent | Thornber LANTOR GROUP ST. HELENS ROAD BOLTON BL3 3PR England, GB |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-05 |
| Decision Date | 1988-10-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50732224710148 | K882756 | 000 |