The following data is part of a premarket notification filed by Alpha-tec Systems, Inc. with the FDA for Ats Para-set Modified Pva Fixative Solution.
| Device ID | K883048 |
| 510k Number | K883048 |
| Device Name: | ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION |
| Classification | Fixative, Alcohol Containing |
| Applicant | ALPHA-TEC SYSTEMS, INC. 18271 MCDURMOTT WEST, STE I Irvine, CA 92714 |
| Contact | Laurie A Williams |
| Correspondent | Laurie A Williams ALPHA-TEC SYSTEMS, INC. 18271 MCDURMOTT WEST, STE I Irvine, CA 92714 |
| Product Code | LDZ |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-16 |
| Decision Date | 1988-08-17 |