The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Puritan-bennett Oxygen Pressure Regulator W/flow..
Device ID | K896152 |
510k Number | K896152 |
Device Name: | PURITAN-BENNETT OXYGEN PRESSURE REGULATOR W/FLOW. |
Classification | Regulator, Pressure, Gas Cylinder |
Applicant | PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
Contact | Marshall Smith |
Correspondent | Marshall Smith PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
Product Code | CAN |
CFR Regulation Number | 868.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-24 |
Decision Date | 1990-01-09 |