The following data is part of a premarket notification filed by North American Medical Products, Inc. with the FDA for Safe-site Needle Cover.
| Device ID | K905305 |
| 510k Number | K905305 |
| Device Name: | SAFE-SITE NEEDLE COVER |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | NORTH AMERICAN MEDICAL PRODUCTS, INC. 6 WHITE FIR DR. Loudonville, NY 12211 |
| Contact | Arthur Gianakos |
| Correspondent | Arthur Gianakos NORTH AMERICAN MEDICAL PRODUCTS, INC. 6 WHITE FIR DR. Loudonville, NY 12211 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-28 |
| Decision Date | 1991-02-12 |