The following data is part of a premarket notification filed by Salter Labs with the FDA for Salter Labs Model #4005 Gas Sampling Tee And Line.
Device ID | K865046 |
510k Number | K865046 |
Device Name: | SALTER LABS MODEL #4005 GAS SAMPLING TEE AND LINE |
Classification | Connector, Airway (extension) |
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 | BZA |
CFR Regulation Number | 868.5810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-12-24 |
Decision Date | 1987-01-15 |