The following data is part of a premarket notification filed by Salter Labs with the FDA for Salter Labs Model #4009 Sample Lines.
Device ID | K894350 |
510k Number | K894350 |
Device Name: | SALTER LABS MODEL #4009 SAMPLE LINES |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
Applicant | SALTER LABS P.O. BOX 608 Arvin, CA 93203 |
Contact | James N Curti |
Correspondent | James N Curti SALTER LABS P.O. BOX 608 Arvin, CA 93203 |
Product Code | CCK |
CFR Regulation Number | 868.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-07-14 |
Decision Date | 1989-10-03 |