The following data is part of a premarket notification filed by Cox Sterile Products, Inc. with the FDA for Cox Rapid Heat Transfer Sterilizer W/12 Min. Cycle.
| Device ID | K881371 |
| 510k Number | K881371 |
| Device Name: | COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE |
| Classification | Sterilizer, Dry Heat |
| Applicant | COX STERILE PRODUCTS, INC. 5115 MCKINNEY AVENUE, SUITE C Dallas, TX 75205 |
| Contact | Cox, D.d.s. |
| Correspondent | Cox, D.d.s. COX STERILE PRODUCTS, INC. 5115 MCKINNEY AVENUE, SUITE C Dallas, TX 75205 |
| Product Code | KMH |
| CFR Regulation Number | 880.6870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-01 |
| Decision Date | 1988-04-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B234KMHRHPRO111115V0 | K881371 | 000 |
| B234KMHCX6220230V163 | K881371 | 000 |
| B234KMHCX6220230V152 | K881371 | 000 |
| B234KMHCX6000115V161 | K881371 | 000 |
| B234KMHCX6000115V150 | K881371 | 000 |
| B234KMHRHPRO9115V4 | K881371 | 000 |
| B234KMHRHPRO9115V3 | K881371 | 000 |
| B234KMHRHPRO111230V1 | K881371 | 000 |