The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Foregger Dome Valves.
Device ID | K844421 |
510k Number | K844421 |
Device Name: | FOREGGER DOME VALVES |
Classification | Gas-machine, Anesthesia |
Applicant | PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
Contact | Hartley C Ericson |
Correspondent | Hartley C Ericson PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
Product Code | BSZ |
CFR Regulation Number | 868.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-15 |
Decision Date | 1985-01-14 |