The following data is part of a premarket notification filed by Ppg Industries, Inc. with the FDA for Sara Satcap.
Device ID | K901132 |
510k Number | K901132 |
Device Name: | SARA SATCAP |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
Applicant | PPG INDUSTRIES, INC. 9910 WIDMER DR. Lenexa, KS 66215 |
Contact | Rodger A Brown |
Correspondent | Rodger A Brown PPG INDUSTRIES, INC. 9910 WIDMER DR. Lenexa, KS 66215 |
Product Code | CCK |
CFR Regulation Number | 868.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-12 |
Decision Date | 1990-05-22 |