The following data is part of a premarket notification filed by Dryden Corp. with the FDA for Dryden Inflatable Mask.
Device ID | K842472 |
510k Number | K842472 |
Device Name: | DRYDEN INFLATABLE MASK |
Classification | Mask, Gas, Anesthetic |
Applicant | DRYDEN CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BSJ |
CFR Regulation Number | 868.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-06-25 |
Decision Date | 1984-07-06 |