The following data is part of a premarket notification filed by Excel Health Care Products with the FDA for Non-absorbent Drapes & Absorbent Towels.
| Device ID | K850960 |
| 510k Number | K850960 |
| Device Name: | NON-ABSORBENT DRAPES & ABSORBENT TOWELS |
| Classification | Drape, Surgical |
| Applicant | EXCEL HEALTH CARE PRODUCTS 5001 HADLEY RD. South Plainfield, NJ 07080 |
| Contact | Michael Shannon |
| Correspondent | Michael Shannon EXCEL HEALTH CARE PRODUCTS 5001 HADLEY RD. South Plainfield, NJ 07080 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-08 |
| Decision Date | 1986-03-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884389538999 | K850960 | 000 |