The following data is part of a premarket notification filed by Plastics Supplies & Products with the FDA for Rt-hood.
Device ID | K790860 |
510k Number | K790860 |
Device Name: | RT-HOOD |
Classification | Hood, Oxygen, Infant |
Applicant | PLASTICS SUPPLIES & PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FOG |
CFR Regulation Number | 868.5700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-05-07 |
Decision Date | 1979-05-29 |