The following data is part of a premarket notification filed by Hood Laboratories with the FDA for Hood Tracheal & Tracheal-bronchial Prostheses.
Device ID | K873742 |
510k Number | K873742 |
Device Name: | HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES |
Classification | Prosthesis, Tracheal, Preformed/molded |
Applicant | HOOD LABORATORIES 575 WASHINGTON ST. Pembroke, MA 02359 |
Contact | William Mccallum,iii |
Correspondent | William Mccallum,iii HOOD LABORATORIES 575 WASHINGTON ST. Pembroke, MA 02359 |
Product Code | NWA |
CFR Regulation Number | 878.3720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-16 |
Decision Date | 1987-10-01 |