The following data is part of a premarket notification filed by Hood Laboratories with the FDA for Hood Nasal Splint.
Device ID | K890599 |
510k Number | K890599 |
Device Name: | HOOD NASAL SPLINT |
Classification | Splint, Nasal |
Applicant | HOOD LABORATORIES 575 WASHINGTON ST. Pembroke, MA 02359 |
Contact | Lewis H Marten |
Correspondent | Lewis H Marten HOOD LABORATORIES 575 WASHINGTON ST. Pembroke, MA 02359 |
Product Code | EPP |
CFR Regulation Number | 874.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-06 |
Decision Date | 1989-03-17 |