The following data is part of a premarket notification filed by North American Medical Products, Inc. with the FDA for D.l. Scope Blade & Handle.
Device ID | K841778 |
510k Number | K841778 |
Device Name: | D.L. SCOPE BLADE & HANDLE |
Classification | Laryngoscope, Rigid |
Applicant | NORTH AMERICAN MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | CCW |
CFR Regulation Number | 868.5540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-30 |
Decision Date | 1984-05-23 |