The following data is part of a premarket notification filed by Ann Arbor Plastics, Inc. with the FDA for Medium Size Oxygen Hood #1547.
Device ID | K802653 |
510k Number | K802653 |
Device Name: | MEDIUM SIZE OXYGEN HOOD #1547 |
Classification | Tent, Oxygen |
Applicant | ANN ARBOR PLASTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BYL |
CFR Regulation Number | 868.5700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-10-24 |
Decision Date | 1980-11-24 |