The following data is part of a premarket notification filed by Custom Medical Products, Ltd. with the FDA for Sterile Equipment Covers.
| Device ID | K931417 |
| 510k Number | K931417 |
| Device Name: | STERILE EQUIPMENT COVERS |
| Classification | Cover, Barrier, Protective |
| Applicant | CUSTOM MEDICAL PRODUCTS, LTD. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Contact | Carolann Kotula-cook |
| Correspondent | Carolann Kotula-cook CUSTOM MEDICAL PRODUCTS, LTD. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Product Code | MMP |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-22 |
| Decision Date | 1995-07-06 |