The following data is part of a premarket notification filed by Life Shield Healthcare Products, Inc. with the FDA for Connectors And Airway Extensions.
Device ID | K931036 |
510k Number | K931036 |
Device Name: | CONNECTORS AND AIRWAY EXTENSIONS |
Classification | Connector, Airway (extension) |
Applicant | LIFE SHIELD HEALTHCARE PRODUCTS, INC. 15381 STONY CREEK WAY Noblesville, IN 46060 |
Contact | Timothy Struthers |
Correspondent | Timothy Struthers LIFE SHIELD HEALTHCARE PRODUCTS, INC. 15381 STONY CREEK WAY Noblesville, IN 46060 |
Product Code | BZA |
CFR Regulation Number | 868.5810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-01 |
Decision Date | 1993-04-08 |