The following data is part of a premarket notification filed by Primeline Medical Products, Inc. with the FDA for Primagard Surgical Gowns.
| Device ID | K023266 |
| 510k Number | K023266 |
| Device Name: | PRIMAGARD SURGICAL GOWNS |
| Classification | Gown, Surgical |
| Applicant | PRIMELINE MEDICAL PRODUCTS, INC. 1591 FOUR ROD RD. Alden, NY 14004 |
| Contact | David Power |
| Correspondent | David Power PRIMELINE MEDICAL PRODUCTS, INC. 1591 FOUR ROD RD. Alden, NY 14004 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-30 |
| Decision Date | 2002-11-08 |
| Summary: | summary |