The following data is part of a premarket notification filed by Dryden Corp. with the FDA for Dryden Bacteria Filter.
Device ID | K792097 |
510k Number | K792097 |
Device Name: | DRYDEN BACTERIA FILTER |
Classification | Filter, Bacterial, Breathing-circuit |
Applicant | DRYDEN CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAH |
CFR Regulation Number | 868.5260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-10-18 |
Decision Date | 1979-11-13 |