The following data is part of a premarket notification filed by Accutron, Inc. with the FDA for Universal Low Profile Nasal Hoods(1250,1275,1350,1450,1475,1550).
| Device ID | K970046 |
| 510k Number | K970046 |
| Device Name: | UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550) |
| Classification | Mask, Scavenging |
| Applicant | ACCUTRON, INC. 2020 WEST MELINDA LN. Phoenix, AZ 85027 |
| Contact | James R Moore |
| Correspondent | James R Moore ACCUTRON, INC. 2020 WEST MELINDA LN. Phoenix, AZ 85027 |
| Product Code | KHA |
| CFR Regulation Number | 868.5590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-06 |
| Decision Date | 1997-03-28 |