The following data is part of a premarket notification filed by Dryden Corp. with the FDA for Bag-tail Bleed Valve.
Device ID | K870859 |
510k Number | K870859 |
Device Name: | BAG-TAIL BLEED VALVE |
Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
Applicant | DRYDEN CORP. 10640 EAST 59TH ST. P.O. BOX 36038 Indianapolis, IN 46236 |
Contact | Paul E Dryden |
Correspondent | Paul E Dryden DRYDEN CORP. 10640 EAST 59TH ST. P.O. BOX 36038 Indianapolis, IN 46236 |
Product Code | CAI |
CFR Regulation Number | 868.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-03 |
Decision Date | 1987-08-03 |