The following data is part of a premarket notification filed by Bio-dyne, Inc. with the FDA for Biodyne Instrument Wipes.
| Device ID | K900691 |
| 510k Number | K900691 |
| Device Name: | BIODYNE INSTRUMENT WIPES |
| Classification | Gauze, External (with Drug/biologic/animal Source Material) |
| Applicant | BIO-DYNE, INC. 4444 TOPA TOPA DR. La Mesa, CA 92041 |
| Contact | Elizabeth Melaragno |
| Correspondent | Elizabeth Melaragno BIO-DYNE, INC. 4444 TOPA TOPA DR. La Mesa, CA 92041 |
| Product Code | GER |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-13 |
| Decision Date | 1990-03-08 |