The following data is part of a premarket notification filed by Cottrell, Ltd. with the FDA for Endo-spor Plus / Hyprocide.
| Device ID | K972708 |
| 510k Number | K972708 |
| Device Name: | ENDO-SPOR PLUS / HYPROCIDE |
| Classification | Sterilant, Medical Devices |
| Applicant | COTTRELL, LTD. 7399 SOUTH TUCSON WAY Englewood, CO 80112 |
| Contact | Jack Scoville |
| Correspondent | Jack Scoville COTTRELL, LTD. 7399 SOUTH TUCSON WAY Englewood, CO 80112 |
| Product Code | MED |
| CFR Regulation Number | 880.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-21 |
| Decision Date | 1999-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00615375003688 | K972708 | 000 |
| 00864780000311 | K972708 | 000 |