The following data is part of a premarket notification filed by Microgon, Inc. with the FDA for Dyna Gard Syringe Filter.
| Device ID | K852996 |
| 510k Number | K852996 |
| Device Name: | DYNA GARD SYRINGE FILTER |
| Classification | Filter, Infusion Line |
| Applicant | MICROGON, INC. 23152 VERDUGO DR. Laguna Hills, CA 92653 |
| Contact | James J Cronin |
| Correspondent | James J Cronin MICROGON, INC. 23152 VERDUGO DR. Laguna Hills, CA 92653 |
| Product Code | FPB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-15 |
| Decision Date | 1985-09-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850301007617 | K852996 | 000 |
| 00850301007594 | K852996 | 000 |