The following data is part of a premarket notification filed by Concord/portex with the FDA for Suction Control Valve.
Device ID | K892343 |
510k Number | K892343 |
Device Name: | SUCTION CONTROL VALVE |
Classification | Catheters, Suction, Tracheobronchial |
Applicant | CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
Contact | Robert Wheeler |
Correspondent | Robert Wheeler CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
Product Code | BSY |
CFR Regulation Number | 868.6810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-05 |
Decision Date | 1989-04-24 |