The following data is part of a premarket notification filed by Suncoast Medical Products, Inc. with the FDA for Wound Care Compression System (wccs).
| Device ID | K960585 |
| 510k Number | K960585 |
| Device Name: | WOUND CARE COMPRESSION SYSTEM (WCCS) |
| Classification | Wound Dressing Kit |
| Applicant | SUNCOAST MEDICAL PRODUCTS, INC. 911 LAKESIDE DR. Cargo, FL 33778 |
| Contact | Jack S Borowsky |
| Correspondent | Jack S Borowsky SUNCOAST MEDICAL PRODUCTS, INC. 911 LAKESIDE DR. Cargo, FL 33778 |
| Product Code | MCY |
| CFR Regulation Number | 880.5075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-12 |
| Decision Date | 1996-04-26 |