The following data is part of a premarket notification filed by Dyna-tek Industries with the FDA for De-tox Control 1 And De-tox Control 19.
| Device ID | K964771 |
| 510k Number | K964771 |
| Device Name: | DE-TOX CONTROL 1 AND DE-TOX CONTROL 19 |
| Classification | Drug Mixture Control Materials |
| Applicant | DYNA-TEK INDUSTRIES 8971 HALL DR. Lenexa, KS 66219 |
| Contact | S. P. Sood |
| Correspondent | S. P. Sood DYNA-TEK INDUSTRIES 8971 HALL DR. Lenexa, KS 66219 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-27 |
| Decision Date | 1997-02-04 |