The following data is part of a premarket notification filed by Medical Specialty Innovations, Inc. (msi) with the FDA for Msi Surgical Drapes.
| Device ID | K974672 |
| 510k Number | K974672 |
| Device Name: | MSI SURGICAL DRAPES |
| Classification | Drape, Surgical |
| Applicant | MEDICAL SPECIALTY INNOVATIONS, INC. (MSI) 55 NORTHERN BLVD. Great Neck, NY 11021 |
| Contact | Carolann Kotula |
| Correspondent | Carolann Kotula MEDICAL SPECIALTY INNOVATIONS, INC. (MSI) 55 NORTHERN BLVD. Great Neck, NY 11021 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-15 |
| Decision Date | 1998-03-13 |