The following data is part of a premarket notification filed by Thayer Medical Corp. with the FDA for Quick Connect T Adaptor.
Device ID | K882341 |
510k Number | K882341 |
Device Name: | QUICK CONNECT T ADAPTOR |
Classification | Set, Tubing And Support, Ventilator (w Harness) |
Applicant | THAYER MEDICAL CORP. 8141 E. MCLAREN P.O. BOX 57907 Tucson, AZ 85715 |
Contact | David Sladek |
Correspondent | David Sladek THAYER MEDICAL CORP. 8141 E. MCLAREN P.O. BOX 57907 Tucson, AZ 85715 |
Product Code | BZO |
CFR Regulation Number | 868.5975 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-07 |
Decision Date | 1988-07-18 |