The following data is part of a premarket notification filed by Cox-uphuff Intl. with the FDA for Ligature Carrier/packer, Hydroxylapatite.
Device ID | K874342 |
510k Number | K874342 |
Device Name: | LIGATURE CARRIER/PACKER, HYDROXYLAPATITE |
Classification | Carrier, Ligature |
Applicant | COX-UPHUFF INTL. P.O. BOX 40288 Santa Barbara, CA 93140 |
Contact | David J Schuessler |
Correspondent | David J Schuessler COX-UPHUFF INTL. P.O. BOX 40288 Santa Barbara, CA 93140 |
Product Code | GEJ |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-20 |
Decision Date | 1987-11-13 |