The following data is part of a premarket notification filed by Primeline Medical Products, Inc. with the FDA for Primagard Surgical Equipment Drapes.
| Device ID | K022868 |
| 510k Number | K022868 |
| Device Name: | PRIMAGARD SURGICAL EQUIPMENT DRAPES |
| Classification | Drape, Surgical |
| Applicant | PRIMELINE MEDICAL PRODUCTS, INC. 10707-100TH AVE., SUITE 300 Edmonton, Alberta, CA T5j 3m1 |
| Contact | Brenda Lee |
| Correspondent | Brenda Lee PRIMELINE MEDICAL PRODUCTS, INC. 10707-100TH AVE., SUITE 300 Edmonton, Alberta, CA T5j 3m1 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-29 |
| Decision Date | 2002-11-08 |
| Summary: | summary |