The following data is part of a premarket notification filed by On Site Gas Systems, Inc. with the FDA for Pogs 33.
Device ID | K030920 |
510k Number | K030920 |
Device Name: | POGS 33 |
Classification | Generator, Oxygen, Portable |
Applicant | ON SITE GAS SYSTEMS, INC. 35 BUDNEY RD. BUDNEY INDUSTRIAL PARK Newington,, CT 06111 |
Contact | Francis X Hursey |
Correspondent | Francis X Hursey ON SITE GAS SYSTEMS, INC. 35 BUDNEY RD. BUDNEY INDUSTRIAL PARK Newington,, CT 06111 |
Product Code | CAW |
CFR Regulation Number | 868.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-03-24 |
Decision Date | 2004-03-10 |
Summary: | summary |