The following data is part of a premarket notification filed by Healthdyne Cardiovascular, Inc. with the FDA for Dressing Change Kit.
| Device ID | K900665 |
| 510k Number | K900665 |
| Device Name: | DRESSING CHANGE KIT |
| Classification | Mask, Surgical |
| Applicant | HEALTHDYNE CARDIOVASCULAR, INC. 45 PARKER ST., SUITE A Irvine, CA 92618 -1658 |
| Contact | Bill Welch |
| Correspondent | Bill Welch HEALTHDYNE CARDIOVASCULAR, INC. 45 PARKER ST., SUITE A Irvine, CA 92618 -1658 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-13 |
| Decision Date | 1990-05-14 |