The following data is part of a premarket notification filed by North American Medical Products, Inc. with the FDA for Port-o-scope(tm).
| Device ID | K895948 |
| 510k Number | K895948 |
| Device Name: | PORT-O-SCOPE(TM) |
| Classification | Bronchoscope (flexible Or Rigid) |
| 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 | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-10 |
| Decision Date | 1990-03-27 |