The following data is part of a premarket notification filed by Acacia Laboratories, Inc. with the FDA for Hydracare Absorbent Wound Dressing.
| Device ID | K951914 |
| 510k Number | K951914 |
| Device Name: | HYDRACARE ABSORBENT WOUND DRESSING |
| Classification | Bandage, Liquid |
| Applicant | ACACIA LABORATORIES, INC. 1719 SOUTH GRAND AVE. Santa Ana, CA 92705 -4808 |
| Contact | Philip L Ritger |
| Correspondent | Philip L Ritger ACACIA LABORATORIES, INC. 1719 SOUTH GRAND AVE. Santa Ana, CA 92705 -4808 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-24 |
| Decision Date | 1995-05-15 |