The following data is part of a premarket notification filed by N.m. Beale Co. Inc. with the FDA for Pef Tube.
| Device ID | K071579 |
| 510k Number | K071579 |
| Device Name: | PEF TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | N.M. BEALE CO. INC. 5 WHITCOMB AVENEUE Ayer, MA 01432 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau N.M. BEALE CO. INC. 5 WHITCOMB AVENEUE Ayer, MA 01432 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-08 |
| Decision Date | 2007-11-20 |
| Summary: | summary |