The following data is part of a premarket notification filed by Intertech Resources, Inc. with the FDA for Pft Filter.
Device ID | K952062 |
510k Number | K952062 |
Device Name: | PFT FILTER |
Classification | Filter, Bacterial, Breathing-circuit |
Applicant | INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
Contact | Avia Toney |
Correspondent | Avia Toney INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
Product Code | CAH |
CFR Regulation Number | 868.5260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-02 |
Decision Date | 1995-06-08 |