The following data is part of a premarket notification filed by North American Medical Products, Inc. with the FDA for D.l. Scope(r) Otoscope.
| Device ID | K862661 |
| 510k Number | K862661 |
| Device Name: | D.L. SCOPE(R) OTOSCOPE |
| Classification | Otoscope |
| 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 | ERA |
| CFR Regulation Number | 874.4770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-14 |
| Decision Date | 1986-08-08 |