The following data is part of a premarket notification filed by N.m. Beale Co. Inc. with the FDA for Scope Introducer Model 7400.
| Device ID | K093329 |
| 510k Number | K093329 |
| Device Name: | SCOPE INTRODUCER MODEL 7400 |
| Classification | Endoscope Channel Accessory |
| Applicant | N.M. BEALE CO. INC. 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau N.M. BEALE CO. INC. 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-26 |
| Decision Date | 2010-02-16 |
| Summary: | summary |