The following data is part of a premarket notification filed by Excel Health Care Products with the FDA for Sterile Film Drape Fenestrated W/adhesive Patch.
| Device ID | K850326 |
| 510k Number | K850326 |
| Device Name: | STERILE FILM DRAPE FENESTRATED W/ADHESIVE PATCH |
| Classification | Drape, Surgical |
| Applicant | EXCEL HEALTH CARE PRODUCTS 5001 HADLEY RD. South Plainfield, NJ 07080 |
| Contact | David Catlin |
| Correspondent | David Catlin 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 | 1985-01-28 |
| Decision Date | 1985-02-26 |