The following data is part of a premarket notification filed by Busse Hospital Disposables, Inc. with the FDA for Hydrophilic Foam Dressing.
| Device ID | K953019 |
| 510k Number | K953019 |
| Device Name: | HYDROPHILIC FOAM DRESSING |
| Classification | Bandage, Liquid |
| Applicant | BUSSE HOSPITAL DISPOSABLES, INC. P.O. BOX 11067 Hauppauge, NY 11788 |
| Contact | Eileen Rama |
| Correspondent | Eileen Rama BUSSE HOSPITAL DISPOSABLES, INC. P.O. BOX 11067 Hauppauge, NY 11788 |
| 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 | 1995-06-29 |
| Decision Date | 1995-09-15 |