The following data is part of a premarket notification filed by Dryden Corp. with the FDA for Reuseable Non-conductive Fixed Y.
Device ID | K841455 |
510k Number | K841455 |
Device Name: | REUSEABLE NON-CONDUCTIVE FIXED Y |
Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
Applicant | DRYDEN CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAI |
CFR Regulation Number | 868.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-09 |
Decision Date | 1984-06-11 |