The following data is part of a premarket notification filed by Accutron, Inc. with the FDA for Pip Low Profile Scavenging System(260 And 261)/universal Low Profile Scavenging System(260-u And 261-u).
| Device ID | K965239 |
| 510k Number | K965239 |
| Device Name: | PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U) |
| Classification | Apparatus, Gas-scavenging |
| Applicant | ACCUTRON, INC. 2020 WEST MELINDA LN. Phoenix, AZ 85027 |
| Contact | Jim Moore |
| Correspondent | Jim Moore ACCUTRON, INC. 2020 WEST MELINDA LN. Phoenix, AZ 85027 |
| Product Code | CBN |
| CFR Regulation Number | 868.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-31 |
| Decision Date | 1997-03-28 |