The following data is part of a premarket notification filed by Alpha-tec Systems, Inc. with the FDA for Ats Pva Fixative Solution.
| Device ID | K881698 |
| 510k Number | K881698 |
| Device Name: | ATS 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 | 1988-04-19 |
| Decision Date | 1988-05-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816085020273 | K881698 | 000 |
| 00816085022468 | K881698 | 000 |
| 00816085022499 | K881698 | 000 |
| 00816085022505 | K881698 | 000 |
| 00816085022512 | K881698 | 000 |
| 00816085024059 | K881698 | 000 |
| 00816085020266 | K881698 | 000 |
| 00816085021287 | K881698 | 000 |
| 00816085021294 | K881698 | 000 |
| 00816085022444 | K881698 | 000 |
| 00816085022376 | K881698 | 000 |
| 00816085020914 | K881698 | 000 |
| 00816085021010 | K881698 | 000 |
| 00816085021027 | K881698 | 000 |
| 00816085021034 | K881698 | 000 |
| 00816085021041 | K881698 | 000 |
| 00816085021058 | K881698 | 000 |
| 00816085021065 | K881698 | 000 |
| 00816085021942 | K881698 | 000 |
| 00816085021515 | K881698 | 000 |
| 00816085021546 | K881698 | 000 |
| 00816085021539 | K881698 | 000 |
| 00816085023236 | K881698 | 000 |
| 00816085023243 | K881698 | 000 |
| 00816085023366 | K881698 | 000 |
| 00816085023373 | K881698 | 000 |
| 00816085024042 | K881698 | 000 |
| 00816085020792 | K881698 | 000 |
| 00816085021591 | K881698 | 000 |
| 00816085023557 | K881698 | 000 |
| 00816085023229 | K881698 | 000 |
| 00816085023212 | K881698 | 000 |
| 00816085022161 | K881698 | 000 |
| 00816085022277 | K881698 | 000 |
| 00816085022307 | K881698 | 000 |
| 00816085022451 | K881698 | 000 |
| 00816085022475 | K881698 | 000 |
| 00816085022482 | K881698 | 000 |
| 00816085022963 | K881698 | 000 |
| 00816085023205 | K881698 | 000 |
| 00816085022437 | K881698 | 000 |